Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia
A 52-week, Phase III, Open-label, Multi-center Study to Evaluate Efficacy and Safety of GSK1278863 in Japanese Non-dialysis and Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Aichi、日本、455-8530
- GSK Investigational Site
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Aichi、日本、457-8511
- GSK Investigational Site
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Aichi、日本、453-8566
- GSK Investigational Site
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Aichi、日本、486-8510
- GSK Investigational Site
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Chiba、日本、260-8712
- GSK Investigational Site
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Chiba、日本、278-0004
- GSK Investigational Site
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Ehime、日本、790-0024
- GSK Investigational Site
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Fukui、日本、910-8526
- GSK Investigational Site
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Fukuoka、日本、802-8555
- GSK Investigational Site
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Fukuoka、日本、820-8505
- GSK Investigational Site
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Fukushima、日本、963-8052
- GSK Investigational Site
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Gifu、日本、500-8717
- GSK Investigational Site
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Gifu、日本、500-8523
- GSK Investigational Site
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Hiroshima、日本、720-0838
- GSK Investigational Site
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Hokkaido、日本、060-0033
- GSK Investigational Site
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Hokkaido、日本、007-0803
- GSK Investigational Site
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Hokkaido、日本、065-8611
- GSK Investigational Site
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Hokkaido、日本、073-0022
- GSK Investigational Site
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Hokkaido、日本、073-0196
- GSK Investigational Site
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Ibaraki、日本、310-0015
- GSK Investigational Site
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Ibaraki、日本、302-0022
- GSK Investigational Site
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Ibaraki、日本、306-0433
- GSK Investigational Site
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Ishikawa、日本、920-0353
- GSK Investigational Site
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Ishikawa、日本、920-8530
- GSK Investigational Site
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Iwate、日本、020-0066
- GSK Investigational Site
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Kagoshima、日本、890-0073
- GSK Investigational Site
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Kagoshima、日本、893-0024
- GSK Investigational Site
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Kagoshima、日本、899-5431
- GSK Investigational Site
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Kanagawa、日本、210-0852
- GSK Investigational Site
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Kanagawa、日本、234-8503
- GSK Investigational Site
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Kanagawa、日本、242-0018
- GSK Investigational Site
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Kanagawa、日本、251-8550
- GSK Investigational Site
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Kumamoto、日本、861-8520
- GSK Investigational Site
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Kumamoto、日本、862-8505
- GSK Investigational Site
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Kyoto、日本、604-8845
- GSK Investigational Site
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Kyoto、日本、611-0041
- GSK Investigational Site
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Kyoto、日本、612-8555
- GSK Investigational Site
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Nagano、日本、396-8555
- GSK Investigational Site
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Nagano、日本、399-8292
- GSK Investigational Site
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Oita、日本、874-0011
- GSK Investigational Site
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Osaka、日本、530-0012
- GSK Investigational Site
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Osaka、日本、530-8480
- GSK Investigational Site
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Osaka、日本、555-0001
- GSK Investigational Site
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Osaka、日本、558-8558
- GSK Investigational Site
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Osaka、日本、586-8521
- GSK Investigational Site
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Osaka、日本、591-8025
- GSK Investigational Site
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Saitama、日本、330-8553
- GSK Investigational Site
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Saitama、日本、335-0023
- GSK Investigational Site
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Shiga、日本、523-0082
- GSK Investigational Site
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Shizuoka、日本、425-8505
- GSK Investigational Site
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Tokushima、日本、770-0011
- GSK Investigational Site
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Tokyo、日本、141-8625
- GSK Investigational Site
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Tottori、日本、683-0002
- GSK Investigational Site
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Toyama、日本、932-8503
- GSK Investigational Site
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Toyama、日本、937-0042
- GSK Investigational Site
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Toyama、日本、938-8502
- GSK Investigational Site
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age (at the time of informed consent): >=20 years of age
- Screening verification only: Stage of chronic kidney disease (CKD) (ND subjects only): CKD stages 3, 4, and 5 defined by estimated glomerular filtration rate (eGFR) using the Japanese Society of Nephrology-Chronic Kidney Disease Initiatives (JSN-CKDI) formula
Dialysis:
- Not on dialysis for at least 12 weeks prior to screening (ND subjects)
- On peritoneal dialysis (PD subjects)
Use of ESA:
- ESA non-users: Have not used ESAs for 8 weeks prior to screening
- ESA users: Have used the same ESA for 8 weeks prior to screening. However, in the ND subjects, the dose of darbepoetin alfa or epoetin beta pegol must be stable (administered once every 4 weeks and up to one-step dose change during 8 weeks prior to screening).
Hgb: Determined at the site using an Hgb analyzer
- ESA non-users: >=8.0 g/dL and <11.0 g/dL
- ESA users: >=9.0 g/dL and <=13.0 g/dL
- Iron parameters: Ferritin >100 nanograms per milliliters (ng/mL) or transferrin saturation (TSAT) >20% (screening verification only)
Gender (screening verification only): Female or male. Females: Not pregnant [demonstrated to be negative for human chorionic gonadotropin (hCG) in urine or serum], not breast-feeding, and meet at least one of the following:
Females of non-childbearing potential are defined as follows:
- Pre-menopausal with at least one of the following and no plans to utilize assisted reproductive techniques (e.g., in vitro fertilization or donor embryo transfer):
- History of bilateral tubal ligation or salpingectomy
- History of hysteroscopic tubal occlusion and postoperatively documented bilateral tubal obstruction
- History of hysterectomy
- History of bilateral oophorectomy
- Postmenopausal defined as: females 60 years of age or older or ; In females <60 years of age, 12 months of spontaneous amenorrhea (in questionable cases a blood sample with postmenopausal follicle stimulating hormone [FSH] and estradiol concentrations is confirmatory [specified reference ranges]). Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will be required to use one of the most effective contraception methods if they wish to continue their HRT during the study. Otherwise they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
- Females of childbearing potential must agree to comply with one of the contraception methods listed as requirements in "GSK Listing of Most Effective Contraceptive Methods for Females of Childbearing Potential" from 28 days prior to the first dose of study medication until the completion of the follow-up visit (for subjects randomized to the GSK1278863 group) or 7 weeks after the last dose of study treatment (for subjects randomized to the Epoetin beta pegol group).
- Informed consent: Written informed consent, including adherence to the requirements and conditions specified in the consent form and the protocol, must be obtained from each subject as specified in Protocol.
Exclusion Criteria:
Chronic kidney disease (CKD)-related criteria
Dialysis
- Cohort 1 and Cohort 3: Start or plan to initiate dialysis during the study
- Cohort 2: Plan to stop peritoneal dialysis or start hemodialysis during the study
- Kidney transplant: Planned living-related kidney transplant during the study Anemia-related criteria
- Aplasia: History of bone-marrow hypoplasia or pure red cell aplasia
- Other causes of anemia: pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes
- Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease OR clinically significant GI bleeding within 8 weeks prior to screening or during a period from screening to Day 1.
Cardiovascular disease-related criteria
- Myocardial infarction, acute coronary syndrome, stroke, or transient ischemic attack: Diagnosed within 8 weeks prior to screening or during a period from screening to Day 1.
- Heart failure: Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system
- QT interval corrected for heart rate (QTc) (screening verification only): QTc >500 milliseconds (msec) or QTc >530 msec in subjects with bundle branch block Note: QT interval corrected using the Bazett's formula (QTcB) will be used, and Electrocardiogram (ECG) can be mechanically or manually read.
Other disease-related criteria
Liver disease (if any of the following occurs):
- (Screening verification only) Alanine transaminase (ALT) >2 times upper limit of normal (ULN)
- (Screening verification only) Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%)
- Current unstable active liver or biliary disease (generally defined by the onset of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, persistent jaundice, or cirrhosis) Note: Stable liver disease (including asymptomatic gallstones, chronic hepatitis B/C, or Gilbert's syndrome) is acceptable if the subject otherwise meets entry criteria..
- Malignancy: History of malignancy within 2 years prior to screening, or currently receiving treatment for cancer, (PD subjects only) complex renal cystic >3 centimeters (cm) (II F, III or IV based on the Bosniak classification) Note (ND subjects and PD subjects): The only exception is squamous cell or basal cell carcinoma of the skin that has been definitively treated >=8 weeks before screening.
- In the opinion of the investigator, Hgb increase to the target range (11.0-13.0 g/dL) is medically risky.
Concomitant medication and other study treatment-related criteria
- Iron: Planned use of intravenous iron during the screening phase or during a period from Day 1 to Week 4 Note: Oral iron is acceptable. However, the same dose regimen must be used throughout the screening phase and from Day 1 to Week 4. Antihyperphosphatemic agents containing iron (e.g., ferric citrate hydrate) are also acceptable only if used for at least 12 weeks prior to screening. However, they must be continued throughout the screening phase from Day 1 to Week 4.
- Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product or epoetin beta pegol
- Drugs and supplements: Use or planned use of any prescription or non-prescription drugs or dietary supplements that are prohibited during the study period (prohibited medications: strong inducers and inhibitor of Cytochrome P450 2C8 [CYP2C8])
- Prior investigational product exposure: Use of an investigational agent within 30 days or five half lives of the investigational agent (whichever is longer)
- Prior treatment with GSK1278863: Any prior treatment with GSK1278863 for a treatment duration of >30 days
General health-related criteria
- Other conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the investigator (or subinvestigator) considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Daprodustat in ND participants
Eligible ND participants will receive oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams [mg] as recommended) dose once daily for 52 weeks.
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7.0 millimeters (mm) round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, or 4 mg of GSK1278863 as active ingredient, to be orally administered once daily.
9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of GSK1278863 as active ingredient, to be orally administered once daily.
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アクティブコンパレータ:Epoetin beta pegol in ND participants
Eligible ND participants will receive subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram [µg] as recommended) dose once every 2 or 4 weeks for 52 weeks.
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An injectable formulation containing 25 micrograms µg, 50 µg, 75 µg, 100 µg, 150 µg, 200 µg, or 250 µg of epoetin beta pegol per syringe (0.3 mL), supplied as a glass syringe prefilled with epoetin beta pegol solution (clear colorless to pale yellow).
Epoetin beta pegol will be subcutaneously administered once every 2 or 4 weeks.
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実験的:Daprodustat in PD participants
Eligible PD participants will receive oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 mg as recommended) dose once daily for 52 weeks.
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7.0 millimeters (mm) round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, or 4 mg of GSK1278863 as active ingredient, to be orally administered once daily.
9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of GSK1278863 as active ingredient, to be orally administered once daily.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants
時間枠:Weeks 40 to 52
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The mean hemoglobin during the primary efficacy evaluation period in ND participants was estimated by a statistical model using Mixed Model Repeated Measures (MMRM).
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Weeks 40 to 52
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)
時間枠:Weeks 40 to 52
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ND participants with observed mean Hgb within the target range during the primary efficacy evaluation period were summarized.
Responders were defined as the participants with the mean Hgb within target range during the primary efficacy evaluation period.
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Weeks 40 to 52
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Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)
時間枠:Weeks 40 to 52
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The percentage of ND participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized.
Responders were defined as the participants with the mean Hgb within target range during the primary efficacy evaluation period.
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Weeks 40 to 52
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Change From Baseline in Hgb at Week 4 in ND Participants
時間枠:Baseline (Day 1) and Week 4
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Baseline Hgb value was the value from the Day 1 visit.
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Data for change from Baseline in Hgb at Week 4 in ND participants is presented.
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Baseline (Day 1) and Week 4
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Change From Baseline in Hgb at Week 4 in PD Participants
時間枠:Baseline (Day 1) and Week 4
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Baseline Hgb value was the value from the Day 1 visit.
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Data for change from Baseline in Hgb at week 4 in PD participants is presented.
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Baseline (Day 1) and Week 4
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Number of ND Participants by Hgb Change From Baseline Category at Week 4
時間枠:Baseline (Day 1) and Week 4
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Baseline Hgb value was the value from the Day 1 visit.
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Number of participants by Hgb change from Baseline is categorized to <=-2.0, >-2.0 and <=-1.0,
>-1.0 and <=0, >0 and <=1.0, >1.0 and <=2.0, >2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL.
Number of participants have been included in more than one category at Week 4.
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Baseline (Day 1) and Week 4
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Percentage of ND Participants by Hgb Change From Baseline Category at Week 4
時間枠:Baseline (Day 1) and Week 4
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Baseline Hgb value was the value from the Day 1 visit.
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Number of participants by Hgb change from Baseline is categorized to <=-2.0, >-2.0 and <=-1.0,
>-1.0 and <=0, >0 and <=1.0, >1.0 and <=2.0, >2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL.
Number of participants have been included in more than one category at Week 4.
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Baseline (Day 1) and Week 4
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Number of PD Participants by Hgb Change From Baseline Category at Week 4
時間枠:Baseline (Day 1) and Week 4
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Baseline Hgb value was the value from the Day 1 visit.
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Number of participants by Hgb change from Baseline is categorized to <=-2.0, >-2.0 and <=-1.0,
>-1.0 and <=0, >0 and <=1.0, >1.0 and <=2.0, >2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL.
Number of participants have been included in more than one category at Week 4.
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Baseline (Day 1) and Week 4
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Percentage of PD Participants by Hgb Change From Baseline Category at Week 4
時間枠:Baseline (Day 1) and Week 4
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Baseline Hgb value was the value from the Day 1 visit.
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Number of participants by Hgb change from Baseline is categorized to <=-2.0, >-2.0 and <=-1.0,
>-1.0 and <=0, >0 and <=1.0, >1.0 and <=2.0, >2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL.
Number of participants have been included in more than one category at Week 4.
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Baseline (Day 1) and Week 4
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Daprodustat Dose Level by Visit in ND Participants
時間枠:Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
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Daprodustat dose level at each assessment visit for ND participants is presented using 25th percentile (P25), median, and 75th percentile (P75).
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Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
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Epoetin Beta Pegol Dose Level by Visit in ND Participants
時間枠:Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
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Dose of epoetin beta pegol at a scheduled visit was converted to dose per 4 weeks when the dose frequency was every 2 weeks.
Epoetin beta pegol dose level at each assessment visit for ND participants is presented using 25th percentile (P25), median, and 75th percentile (P75).
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Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
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Daprodustat Dose Level by Visit in PD Participants
時間枠:Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
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Daprodustat dose level at each assessment visit for PD participants is presented using 25th percentile (P25), median, and 75th percentile (P75).
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Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48
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Duration of Treatment Interruption Due to Hgb >13 g/dL in ND Participants
時間枠:Up to Week 52
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The duration (in days) of treatment interruption due to Hgb >13 g/dL per participant was summarized descriptively on participants with a period of treatment interruption due to Hgb >13 g/dL.
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Up to Week 52
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Duration of Treatment Interruption Due to Hgb >13 g/dL in PD Participants
時間枠:Up to Week 52
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The duration (in days) of treatment interruption due to Hgb >13 g/dL per participant was summarized descriptively on participants with a period of treatment interruption due to Hgb >13 g/dL.
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Up to Week 52
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Number of Dose Adjustments in ND Participants
時間枠:Up to Week 52
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Number of dose adjustments in ND participants is presented.
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Up to Week 52
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Number of Dose Adjustments in PD Participants
時間枠:Up to Week 52
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Number of dose adjustments in PD participants is presented.
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Up to Week 52
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Hgb Values at Each Assessment Visit in ND Participants
時間枠:Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Hgb values at each assessment visit for ND participants is presented.
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Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Hgb Values at Each Assessment Visit in PD Participants
時間枠:Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Hgb values at each assessment visit for PD participants is presented.
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Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
時間枠:Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Baseline Hgb value was the value from the Day 1 visit.
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Data for change from Baseline in Hgb values at each assessment visit in ND participants is presented.
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Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
時間枠:Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Baseline Hgb value was the value from the Day 1 visit.
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Data for change from Baseline in Hgb values at each assessment visit in PD participants is presented.
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Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
時間枠:Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Number of ND participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.
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Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
時間枠:Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Percentage of ND participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.
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Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
時間枠:Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Number of PD participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.
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Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
時間枠:Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Percentage of PD participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.
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Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
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Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants
時間枠:Weeks 40 to 52
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Mean percentage of time with Hgb within the target range (11.0 to 13.0 g/dL) is summarized during the primary efficacy evaluation period (Weeks 40 to 52).
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Weeks 40 to 52
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Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in PD Participants
時間枠:Weeks 40 to 52
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Mean percentage of time with Hgb within the target range (11.0 to 13.0 g/dL) is summarized during the primary efficacy evaluation period (Weeks 40 to 52).
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Weeks 40 to 52
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Time to Reach the Lower Target Hgb Level (11.0 g/dL) in ND Participants
時間枠:Up to week 52
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The time (in days) to reach the lower target Hgb level (11.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method.
Participants who did not reach the lower Hgb target were considered as censored cases.
Participants who were randomized as Hgb >= 11.0 g/dL were excluded in this summary.
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Up to week 52
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Time to Reach the Lower Target Hgb Level (11.0 g/dL) in PD Participants
時間枠:Up to week 52
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The time (in days) to reach the lower target Hgb level (11.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method.
Participants who did not reach the lower Hgb target were considered as censored cases.
Participants who were randomized as Hgb >= 11.0 g/dL were excluded in this summary.
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Up to week 52
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Number of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL
時間枠:Up to week 52
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Number of ND participants who had an Hgb level of less than 7.5 g/dL is presented.
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Up to week 52
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Percentage of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL
時間枠:Up to week 52
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Percentage of ND participants who had an Hgb level of less than 7.5 g/dL is presented.
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Up to week 52
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Number of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL
時間枠:Up to week 52
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Number of PD participants who had an Hgb level of less than 7.5 g/dL is presented.
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Up to week 52
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Percentage of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL
時間枠:Up to week 52
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Percentage of PD participants who had an Hgb level of less than 7.5 g/dL is presented.
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Up to week 52
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Number of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
時間枠:Up to week 52
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Number of ND participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.
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Up to week 52
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Percentage of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
時間枠:Up to week 52
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Percentage of ND participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.
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Up to week 52
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Number of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
時間枠:Up to week 52
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Number of PD participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.
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Up to week 52
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Percentage of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
時間枠:Up to week 52
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Percentage of PD participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.
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Up to week 52
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Number of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL
時間枠:Up to week 52
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Number of ND participants who had an Hgb level of more than 13.0 g/dL is presented.
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Up to week 52
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Percentage of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL
時間枠:Up to week 52
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Percentage of ND participants who had an Hgb level of more than 13.0 g/dL is presented.
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Up to week 52
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Number of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL
時間枠:Up to week 52
|
Number of PD participants who had an Hgb level of more than 13.0 g/dL is presented.
|
Up to week 52
|
Percentage of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL
時間枠:Up to week 52
|
Percentage of PD participants who had an Hgb level of more than 13.0 g/dL is presented.
|
Up to week 52
|
Number of Episodes With Hgb Level of More Than 13.0 g/dL in ND Participants
時間枠:Up to week 52
|
Number of episodes with Hgb level of more than 13.0 g/dL in ND participants is presented.
|
Up to week 52
|
Number of Episodes With Hgb Level of More Than 13.0 g/dL in PD Participants
時間枠:Up to week 52
|
Number of episodes with Hgb level of more than 13.0 g/dL in PD participants is presented.
|
Up to week 52
|
Monthly Average Dose of Oral Iron During the Treatment Period in ND Participants
時間枠:Up to Week 52
|
Supplemental iron therapy were received by participants if required during treatment period.
Participants who used ferric citrate were counted as oral iron use.
Monthly average oral iron = Total oral iron dose (mg) / (duration in days / 30.4375 days).
Monthly average dose of oral iron during the treatment period in ND participants is presented.
|
Up to Week 52
|
Monthly Average Dose of Oral Iron During the Treatment Period in PD Participants
時間枠:Up to Week 52
|
Supplemental iron therapy were received by participants if required during treatment period.
Participants who used ferric citrate were counted as oral iron use.
Monthly average oral iron = Total oral iron dose (mg) / (duration in days / 30.4375 days).
Monthly average dose of oral iron during the treatment period in PD participants is presented.
|
Up to Week 52
|
Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in ND Participants
時間枠:Weeks 40 to 52
|
Supplemental iron therapy were received by participants if required during treatment period.
Participants who used ferric citrate were counted as oral iron use.
Monthly average oral iron dose during the primary efficacy evaluation period (Weeks 40 to 52) = Total oral iron dose (mg) during the primary efficacy evaluation period / (duration in the period in days / 30.4375 days).
Monthly average dose of oral iron during the primary efficacy evaluation period in ND participants is presented.
|
Weeks 40 to 52
|
Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in PD Participants
時間枠:Weeks 40 to 52
|
Supplemental iron therapy were received by participants if required during treatment period.
Participants who used ferric citrate were counted as oral iron use.
Monthly average oral iron dose during the primary efficacy evaluation period (Weeks 40 to 52) = Total oral iron dose (mg) during the primary efficacy evaluation period / (duration in the period in days / 30.4375 days).
Monthly average dose of oral iron during the primary efficacy evaluation period in PD participants is presented.
|
Weeks 40 to 52
|
Number of ND Participants Who Used Oral Iron During the Treatment Period
時間枠:Up to week 52
|
Supplemental iron therapy were received by participants if required during treatment period.
Participants who used ferric citrate were counted as oral iron use.
The number of ND participants who used oral iron during the treatment period were summarized.
|
Up to week 52
|
Number of PD Participants Who Used Oral Iron During the Treatment Period
時間枠:Up to week 52
|
Supplemental iron therapy were received by participants if required during treatment period.
Participants who used ferric citrate were counted as oral iron use.
The number of PD participants who used oral iron during the treatment period were summarized.
|
Up to week 52
|
Percentage of ND Participants Who Used Oral Iron During the Treatment Period
時間枠:Up to week 52
|
Supplemental iron therapy were received by participants if required during treatment period.
Participants who used ferric citrate were counted as oral iron use.
The percentage of ND participants who used oral iron during the treatment period were summarized.
|
Up to week 52
|
Percentage of PD Participants Who Used Oral Iron During the Treatment Period
時間枠:Up to week 52
|
Supplemental iron therapy were received by participants if required during treatment period.
Participants who used ferric citrate were counted as oral iron use.
The percentage of PD participants who used oral iron during the treatment period were summarized.
|
Up to week 52
|
Number of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period
時間枠:Weeks 40 to 52
|
Supplemental iron therapy were received by participants if required during treatment period.
Participants who used ferric citrate were counted as oral iron use.
The number of ND participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.
|
Weeks 40 to 52
|
Number of PD Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period
時間枠:Weeks 40 to 52
|
Supplemental iron therapy were received by participants if required during treatment period.
Participants who used ferric citrate were counted as oral iron use.
The number of PD participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.
|
Weeks 40 to 52
|
Percentage of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period
時間枠:Weeks 40 to 52
|
Supplemental iron therapy were received by participants if required during treatment period.
Participants who used ferric citrate were counted as oral iron use.
The percentage of ND participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.
|
Weeks 40 to 52
|
Percentage of PD Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period
時間枠:Weeks 40 to 52
|
Supplemental iron therapy were received by participants if required during treatment period.
Participants who used ferric citrate were counted as oral iron use.
The percentage of PD participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.
|
Weeks 40 to 52
|
Change From Baseline in Ferritin in ND Participants
時間枠:Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Change from Baseline in Ferritin in ND participants was summarized at each assessment visit.
The Baseline value was the latest pre-dose assessment (Day 1 pre-dose).
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Adjusted mean and 95% confidence interval for change from Baseline in Ferritin is presented.
For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
|
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Change From Baseline in Ferritin in PD Participants
時間枠:Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Change from Baseline in Ferritin in PD participants was summarized at each assessment visit.
The Baseline value was the latest pre-dose assessment (Day 1 pre-dose).
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Adjusted mean and 95% confidence interval for change from Baseline in Ferritin is presented.
For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
|
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants
時間枠:Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Percent change from Baseline in TSAT in ND participants was summarized at each assessment visit.
The Baseline value was the latest pre-dose assessment (Day 1 pre-dose).
Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1).
Adjusted geometric mean and 95% confidence interval for percent change from Baseline in TSAT is presented.
For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
|
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Percent Change From Baseline in TSAT in PD Participants
時間枠:Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Percent change from Baseline in TSAT in PD participants was summarized at each assessment visit.
The Baseline value was the latest pre-dose assessment (Day 1 pre-dose).
Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1).
Adjusted geometric mean and 95% confidence interval for percent change from Baseline in TSAT is presented.
For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
|
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Percent Change From Baseline in Hepcidin in ND Participants
時間枠:Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Percent change from Baseline in Hepcidin in ND participants was summarized at each assessment visit.
The Baseline value was the latest pre-dose assessment (Day 1 pre-dose).
Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1).
Adjusted geometric mean and 95% confidence interval for percent change from Baseline in Hepcidin is presented.
For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
|
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Percent Change From Baseline in Hepcidin in PD Participants
時間枠:Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Percent change from Baseline in Hepcidin in PD participants was summarized at each assessment visit.
The Baseline value was the latest pre-dose assessment (Day 1 pre-dose).
Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1).
Adjusted geometric mean and 95% confidence interval for percent change from Baseline in Hepcidin is presented.
For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
|
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Change From Baseline in Serum Iron in ND Participants
時間枠:Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Change from Baseline in serum iron in ND participants was summarized at each assessment visit.
The Baseline value was the latest pre-dose assessment (Day 1 pre-dose).
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Adjusted mean and 95% confidence interval for change from Baseline in Serum iron is presented.
For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
|
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Change From Baseline in Serum Iron in PD Participants
時間枠:Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Change from Baseline in serum iron in PD participants was summarized at each assessment visit.
The Baseline value was the latest pre-dose assessment (Day 1 pre-dose).
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Adjusted mean and 95% confidence interval for change from Baseline in Serum iron is presented.
For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
|
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants
時間枠:Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Change from Baseline in TIBC in ND participants was summarized at each assessment visit.
The Baseline value was the latest pre-dose assessment (Day 1 pre-dose).
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Adjusted mean and 95% confidence interval for change from Baseline in TIBC is presented.
For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
|
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Change From Baseline in TIBC in PD Participants
時間枠:Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Change from Baseline in TIBC in PD participants was summarized at each assessment visit.
The Baseline value was the latest pre-dose assessment (Day 1 pre-dose).
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Adjusted mean and 95% confidence interval for change from Baseline in TIBC is presented.
For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
|
Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52
|
Area Under the Concentration-time Curve From Time Zero Extrapolated to 4 Hours (AUC[0-4]) of Daprodustat for All Dose Levels in ND and PD Participants
時間枠:1, 2, 3 and 4 hours post dose at Weeks 12 and 24
|
Blood samples were collected at indicated timepoints.
Pharmacokinetic (PK) parameters of Daprodustat were calculated using non-compartmental method.
AUC (0-4) is presented for combined Week 12 and 24.
Geometric mean and geometric coefficient of variation is presented.
NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.
|
1, 2, 3 and 4 hours post dose at Weeks 12 and 24
|
Maximum Observed Concentration (Cmax) of Daprodustat for All Dose Levels in ND and PD Participants
時間枠:1, 2, 3 and 4 hours post dose at Weeks 12 and 24
|
Blood samples were collected at indicated timepoints.
PK parameters of Daprodustat were calculated using non-compartmental method.
Cmax is presented for combined Week 12 and 24.
Geometric mean and geometric coefficient of variation is presented.
NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.
|
1, 2, 3 and 4 hours post dose at Weeks 12 and 24
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
- Nangaku M, Hamano T, Akizawa T, Tsubakihara Y, Nagai R, Okuda N, Kurata K, Nagakubo T, Jones NP, Endo Y, Cobitz AR. Daprodustat Compared with Epoetin Beta Pegol for Anemia in Japanese Patients Not on Dialysis: A 52-Week Randomized Open-Label Phase 3 Trial. Am J Nephrol. 2021;52(1):26-35. doi: 10.1159/000513103. Epub 2021 Feb 9.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 201753
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- インフォームド コンセント フォーム (ICF)
- 臨床試験報告書(CSR)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
1 to 4 mg tablets of GSK1278863の臨床試験
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H. Lundbeck A/S終了しました
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MorphoSys AGClinigen Healthcare Ltdマーケティング承認済み
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Federal Budgetary Research Institution State Research...完了
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Alexza Pharmaceuticals, Inc.Atlanta Center for Medical Research完了