A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.
2014년 6월 9일 업데이트: Hoffmann-La Roche
A Randomized, Open Label Study Comparing the Effect of CellCept With Therapeutic Drug Monitoring, Tacrolimus and a Corticosteroid-sparing Regimen Versus Fixed Dose CellCept, Tacrolimus and Corticosteroids Maintained up to 6 Months, on Acute Rejection and Safety in Liver Transplant Patients.
This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients.
Patients will be randomized into one of two groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed dose CellCept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day 0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months).
The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
180
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Besancon, 프랑스, 25030
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Bordeaux, 프랑스, 33076
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Caen, 프랑스, 14033
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Clichy, 프랑스, 92118
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Creteil, 프랑스, 94010
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Grenoble, 프랑스, 38043
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Lille, 프랑스, 59037
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Lyon, 프랑스, 69317
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Lyon cedex 3, 프랑스, 69437
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Marseille, 프랑스, 13385
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Montpellier, 프랑스, 34295
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Nice, 프랑스, 06202
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Paris, 프랑스, 75679
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Rennes, 프랑스, 35033
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Toulouse, 프랑스, 31059
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Villejuif, 프랑스, 94804
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- adult patients, >=18 years of age;
- recipient of a first orthotopic liver transplant.
Exclusion Criteria:
- history of organ transplants;
- patient receiving a multi-organ transplant;
- calculated creatinine clearance <=30mL/min before transplant;
- leukocyte count < 2000/mm3 at randomization;
- history of cancer within past 5 years, except for successfully treated basal cell or squamous cell cancer, or in situ cervical cancer;
- pregnant or breast-feeding females, or females of childbearing age not using effective contraception.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: MMF, Adjusted Dose; Tacrolimus; Corticosteroids
Participants received mycophenolate mofetil (MMF) 3 grams per day (g/d), orally (PO), twice per day (BID) with meals from Day 0 to Day 4; the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12. Participants also received tacrolimus adjusted to a target trough level of 8 to (-) 12 nanograms per milliliter (ng/mL) from Day 0 to Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received corticosteroids 10-15 milligrams per kilogram (mg/kg), intravenously (IV), pre-operation on Day 0.
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3 g/d PO BID during meals from Day 0 to Day 4, followed by dose adjustment based on AUC using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12.
다른 이름들:
Target trough level of 8-2 ng/mL from Day 0 to Month 1, adjusted to a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12
10-15 mg/kg IV pre-operation on Day 0
다른 이름들:
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활성 비교기: MMF, Standard Dose; Tacrolimus; Corticosteroids
Participants received MMF 2 g/d, PO, BID with meals from Day 0 to Month 12. Participants also received tacrolimus adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received corticosteroids 10-15 mg/kg, IV, pre-operation on Day 0; followed by 20 mg/d, PO, 4 times per day (QDS) from Day 0 through Month 1; 15 mg/d, PO, 3 times per day (TID) from the end of Month 1 through Month 2; 10 mg/d, PO, BID from the end of Month 2 through Month 3; and 5 mg/d once per day from the end of Month 3 through Month 6.
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Target trough level of 8-2 ng/mL from Day 0 to Month 1, adjusted to a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12
10-15 mg/kg IV pre-operation on Day 0
다른 이름들:
2 g/d PO BID during meals from Day 0 to Month 12
다른 이름들:
20 mg/d QDS from Day 0 through Month 1; 15 mg/day, TID from the end of Month 1 through Month 2; 10 mg/d BID from the end of Month 2 through Month 3; and 5 mg/d once per day from the end of Month 3 through Month 6.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR) According to Banff Criteria up to 12 Months Post-Transplant
기간: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment
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Banff criteria required at least 2 of the 3 following features for a histopathological diagnosis of acute rejection: portal inflammation, bile duct inflammation, and venous endothelial inflammation.
Each item was graded from 0 to 3 where 0 equals (=) mild, 2 = moderate, and 3 = severe.
The sum of the 3 individual scores, from 0 to 9, corresponded to the Rejection Activity Index (RAI).
If RAI = 0, 1, or 2, there was no evidence of rejection.
If RAI = 3, there was borderline acute rejection.
If RAI = 4 or 5, there was mild acute rejection.
If RAI = 6 or 7, there was moderate acute rejection.
If RAI = 8 or 9, there was severe acute rejection.
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Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With Graft Loss
기간: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.
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Graft survival was defined as the time between the randomization date and the graft loss date.
Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.
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Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.
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Graft Survival
기간: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.
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The median time, in months, between randomization and graft loss event.
Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.
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Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.
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Overall Survival (OS) at Month 12 - Percentage of Participants With an Event
기간: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
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OS was defined as the time between the date of randomization and death up to Month 12. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.
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Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
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Overall Survival at Month 12
기간: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
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The median time, in months, between randomization and OS event.
Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.
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Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
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Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review
기간: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
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The percentage of participants with biopsies of grafts evaluated by central review and scored according to Banff criteria at Month 12 post-transplant.
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Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2007년 11월 1일
기본 완료 (실제)
2011년 7월 1일
연구 완료 (실제)
2011년 7월 1일
연구 등록 날짜
최초 제출
2007년 10월 16일
QC 기준을 충족하는 최초 제출
2007년 10월 16일
처음 게시됨 (추정)
2007년 10월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 7월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 6월 9일
마지막으로 확인됨
2014년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ML21273
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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