A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.
2014年6月9日 更新者：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.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
180
段階
- フェーズ 4
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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Besancon、フランス、25030
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Bordeaux、フランス、33076
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Caen、フランス、14033
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Clichy、フランス、92118
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Creteil、フランス、94010
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Grenoble、フランス、38043
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Lille、フランス、59037
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Lyon、フランス、69317
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Lyon cedex 3、フランス、69437
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Marseille、フランス、13385
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Montpellier、フランス、34295
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Nice、フランス、06202
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Paris、フランス、75679
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Rennes、フランス、35033
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Toulouse、フランス、31059
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Villejuif、フランス、94804
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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;
- 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.
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：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.
他の名前：
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
他の名前：
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アクティブコンパレータ：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
他の名前：
2 g/d PO BID during meals from Day 0 to Month 12
他の名前：
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.
他の名前：
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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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Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR) According to Banff Criteria up to 12 Months Post-Transplant
時間枠：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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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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Percentage of Participants With Graft Loss
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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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
2007年11月1日
一次修了 (実際)
2011年7月1日
研究の完了 (実際)
2011年7月1日
試験登録日
最初に提出
2007年10月16日
QC基準を満たした最初の提出物
2007年10月16日
最初の投稿 (見積もり)
2007年10月17日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年7月14日
QC基準を満たした最後の更新が送信されました
2014年6月9日
最終確認日
2014年6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
- ML21273
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