A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia
2016年10月26日 更新者：Hoffmann-La Roche
An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Intravenous Epoetin Alfa to Maintenance Treatment With Intravenous RO0503821 in Hemodialysis Patients With Chronic Renal Anemia.
This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin.
The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
調査の概要
研究の種類
介入
入学 (実際)
91
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35211
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California
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Los Angeles、California、アメリカ、90095
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Illinois
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Maywood、Illinois、アメリカ、60153
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Kentucky
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Louisville、Kentucky、アメリカ、40202-1718
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Michigan
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Detroit、Michigan、アメリカ、48236
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Detroit、Michigan、アメリカ、48202-2689
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Minnesota
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Brooklyn Center、Minnesota、アメリカ、55430
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Nevada
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Las Vegas、Nevada、アメリカ、89106
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New Jersey
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Paterson、New Jersey、アメリカ、07503
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New York
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Brooklyn、New York、アメリカ、11203
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Mineola、New York、アメリカ、11501
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New York、New York、アメリカ、10128
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Tennessee
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Nashville、Tennessee、アメリカ、37232
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West Virginia
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Morgantown、West Virginia、アメリカ、26506
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- adult patients >=18 years of age;
- chronic renal anemia;
- on hemodialysis therapy for at least 3 months;
- receiving iv epoetin alfa during the 2 weeks prior to the run-in period.
Exclusion Criteria:
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：Cohort 1 (RO0503821 [0.25/150 1x/week])
Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV) using a dose conversion factor of 0.25/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks.
After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
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Differing doses and frequencies of iv administration
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実験的：Cohort 2 (RO0503821 [0.25/150 1x/2week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks.
After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
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Differing doses and frequencies of iv administration
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実験的：Cohort 3 (RO0503821 [0.4/150 1x/week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks.
After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
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Differing doses and frequencies of iv administration
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実験的：Cohort 4 (RO0503821 [0.4/150 1x/2week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks.
After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
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Differing doses and frequencies of iv administration
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実験的：Cohort 5 (RO0503821 [0.6/150 1x/week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks.
After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
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Differing doses and frequencies of iv administration
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実験的：Cohort 6 (RO0503821 [0.6/150 1x/2week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks.
After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
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Differing doses and frequencies of iv administration
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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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Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen
時間枠：From Baseline (Day -28 to Day 1) to EOIT (Week 19)
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Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported.
For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks.
Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1).
For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion.
For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.
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From Baseline (Day -28 to Day 1) to EOIT (Week 19)
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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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Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen
時間枠：From Baseline (Day -28 to Day 1) to EOIT (Week 19)
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Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported.
Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1).
For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion.
For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.
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From Baseline (Day -28 to Day 1) to EOIT (Week 19)
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Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths
時間枠：Up to Week 126
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An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.
).
The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period.
As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.
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Up to Week 126
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Number of Participants With Marked Laboratory Abnormalities
時間枠：Up to Week 126
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Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant.
The number of participants with marked lab abnormality across treatment groups were reported and presented.
Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0- 18.0 10^9/L), Platelets (100 - 550 10^9/L), Alanine aminotransferase (ALAT) [0 110 units per litre (U/L)], Alkaline Phosphatase (ALP) (0 - 220 U/L), Aspartate aminotransferase (ASAT) (0 - 80 U/L), Albumin >= 30 g/L, Phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], Potassium (2.9 - 5.8 mmol/L), Glucose (2.80 - 11.10 mmol/L).
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Up to Week 126
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Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis
時間枠：From Baseline (Day -28 to Day 1) to Week 126
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Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value.
Baseline (Day -28 to Day 1) values were calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1).
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From Baseline (Day -28 to Day 1) to Week 126
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Mean Change in Pulse Rate
時間枠：Up to Week 126
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Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles).
The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported.
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Up to Week 126
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2002年3月1日
一次修了 (実際)
2005年6月1日
研究の完了 (実際)
2005年6月1日
試験登録日
最初に提出
2002年10月24日
QC基準を満たした最初の提出物
2002年10月24日
最初の投稿 (見積もり)
2002年10月25日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年12月20日
QC基準を満たした最後の更新が送信されました
2016年10月26日
最終確認日
2016年10月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BA16285
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。