- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02021370
15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific) (DIALOGUE 1)
A Randomized, Placebo-controlled, Double-blind, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of 5 Fixed Doses of BAY85-3934 Administered Orally in the Correction of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease Not Currently Treated With Erythropoiesis-stimulating Agent in Europe and Asia Pacific
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin.
The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.
The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 14 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.
The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this research.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Seoul, 대한민국, 156-755
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Seoul, 대한민국, 03080
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Seoul, 대한민국, 156-707
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Gyeonggido
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Bucheon-si, Gyeonggido, 대한민국, 420-767
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Baden-Württemberg
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Villingen-Schwenningen, Baden-Württemberg, 독일, 78052
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Nordrhein-Westfalen
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Bonn, Nordrhein-Westfalen, 독일, 53127
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Düsseldorf, Nordrhein-Westfalen, 독일, 40210
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Sachsen-Anhalt
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Halle (Saale), Sachsen-Anhalt, 독일, 06097
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Bucharest, 루마니아, 020475
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Constanta, 루마니아, 900591
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Oradea, 루마니아, 410469
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Targu-Mures, 루마니아, 540103
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Gabrovo, 불가리아, 5300
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Lovech, 불가리아, 5500
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Montana, 불가리아, 3400
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Pazardjik, 불가리아, 4400
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Stara Zagora, 불가리아, 6000
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Veliko Tarnovo, 불가리아, 5000
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A Coruña
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Santiago de Compostela, A Coruña, 스페인, 15706
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, 스페인, 08907
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London, 영국, SE5 9RS
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Cambridgeshire
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Cambridge, Cambridgeshire, 영국, CB2 0QQ
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South Yorkshire
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Doncaster, South Yorkshire, 영국, DN2 5LT
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Ashkelon, 이스라엘, 7827804
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Hadera, 이스라엘, 3810101
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Nahariya, 이스라엘, 2210001
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Campania
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Napoli, Campania, 이탈리아, 80138
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Emilia-Romagna
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Modena, Emilia-Romagna, 이탈리아, 41100
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Lombardia
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Cremona, Lombardia, 이탈리아, 26100
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Pavia, Lombardia, 이탈리아, 27100
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Toscana
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Livorno, Toscana, 이탈리아, 57023
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Chiba, 일본, 260-8712
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Fukuoka, 일본, 810-8563
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Nara, 일본, 630-8581
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Fukuoka
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Kitakyushu, Fukuoka, 일본, 802-8555
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Okawa, Fukuoka, 일본, 831-0016
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Hokkaido
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Muroran, Hokkaido, 일본, 050-0083
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Ishikawa
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Hakusan, Ishikawa, 일본, 924-8588
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Iwate
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Morioka, Iwate, 일본, 020-0066
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Kanagawa
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Kamakura, Kanagawa, 일본, 247-8533
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Mie
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Kuwana, Mie, 일본, 511-0061
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Ankara, 칠면조, 06100
- Ankara Univ. Medical Faculty
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Ankara, 칠면조, 06490
- Baskent University Medical Faculty
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Izmir, 칠면조, 03540
- Sifa University Medical Faculty
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Bialystok, 폴란드, 15-540
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Malbork, 폴란드, 82-200
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Poznan, 폴란드, 61-858
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Radom, 폴란드, 26-610
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Szczecin, 폴란드, 70-111
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Zyrardow, 폴란드, 96-300
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Limoges Cedex1, 프랑스, 87042
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Baja, 헝가리, 6500
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Budapest, 헝가리, 1036
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Pecs, 헝가리, 7623
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New South Wales
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Gosford, New South Wales, 호주, 2250
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Victoria
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Melbourne, Victoria, 호주, 3052
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women without childbearing potential
- Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD) at screening
- Estimated glomerular filtration rate of < 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease [MDRD] or the formula according to Matsuo, et al)
- Not on dialysis and not expected to begin dialysis during the treatment period of the study (at least 16 weeks from randomization)
- Not treated with any erythropoiesis-stimulating agent (ESA) within 8 weeks before randomization
- Mean screening Hb concentration </= 10.5 g/dL
- Body weight of 45 kg to 125 kg, inclusive, at screening
Exclusion Criteria:
- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
- Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively treated > 3 years prior to randomization
- Subjects treated with any ESA within the 8 weeks before randomization
- Red blood cell (RBC) containing transfusion within the 8 weeks before randomization
- History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the last 6 months from initial screening visit
- Severe rhythm or conduction disorders (e.g., HR < 50 or > 110 bpm, atrial flutter, prolonged QT > 500 msec, third degree atrioventricular [AV] block)
- New York Heart Association Class III or IV congestive heart failure
- Severe hepatic insufficiency (defined as alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 x the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B and C) or active hepatitis, in the investigator's opinion
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: BAY85-3934 (25mg OD)
25 mg once daily (OD) of BAY85-3934 Morning: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo Evening: 3 tablets matching placebo
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일치하는 위약 태블릿
25mg Tablet
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실험적: BAY85-3934 (50mg OD)
50 mg OD of BAY85-3934 Morning: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo Evening: 3 tablets matching placebo
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일치하는 위약 태블릿
25mg Tablet
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실험적: BAY85-3934 (75mg OD)
75 mg OD of BAY85-3934 Morning: 3 tablets BAY85-3934 25 mg Evening: 3 tablets matching placebo
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일치하는 위약 태블릿
25mg Tablet
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실험적: BAY85-3934 (25mg BID)
25 mg twice daily (BID) of BAY85-3934 Morning and evening: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo
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일치하는 위약 태블릿
25mg Tablet
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실험적: BAY85-3934 (50mg BID)
50 mg BID of BAY85-3934 Morning and evening: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo
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일치하는 위약 태블릿
25mg Tablet
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위약 비교기: Placebo BID
Placebo BID Morning and evening: 3 tablets of placebo matching BAY85-3934 25 mg
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일치하는 위약 태블릿
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
기간: Baseline and week 12 to 16
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Baseline and week 12 to 16
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2차 결과 측정
결과 측정 |
기간 |
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Number of participants with serious adverse events as a measure of safety and tolerability
기간: Up to 16 weeks
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Up to 16 weeks
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Change in local laboratory hemoglobin level from baseline
기간: Baseline up to 12 weeks
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Baseline up to 12 weeks
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Speed of change in hemoglobin level per unit time
기간: Up to 16 weeks
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Up to 16 weeks
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Duration of treatment exposure
기간: Up to 16 weeks
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Up to 16 weeks
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Pharmacodynamics characterized by erythropoietin concentration
기간: Several time points up to 16 weeks
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Several time points up to 16 weeks
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Pharmacodynamics characterized by reticulocyte count
기간: Several time points up to 16 weeks
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Several time points up to 16 weeks
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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