Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients (INTAC)
Phase 4, Randomized, Open-label, Comparative, Multicenter Study to Assess the Safety and Efficacy of Induction Agents, Alemtuzumab, Basiliximab or Rabbit Anti-thymocyte Globulin in Combination With Tacrolimus, MMF, and a Rapid Steroid Withdrawal in Renal Transplant Recipients
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
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California
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Los Angeles、California、アメリカ、90057
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Palo Alto、California、アメリカ、94304
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San Diego、California、アメリカ、92123
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San Francisco、California、アメリカ、94115
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San Francisco、California、アメリカ、94143
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Colorado
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Denver、Colorado、アメリカ、80262
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District of Columbia
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Washington、District of Columbia、アメリカ、20010
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Washington、District of Columbia、アメリカ、20007
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Florida
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Miami、Florida、アメリカ、33136
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Tampa、Florida、アメリカ、33066
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Illinois
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Chicago、Illinois、アメリカ、60611
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Chicago、Illinois、アメリカ、60612
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New Jersey
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Livingston、New Jersey、アメリカ、07039
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New Brunswick、New Jersey、アメリカ、08901
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New York
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Hawthorne、New York、アメリカ、10532
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New York、New York、アメリカ、10032
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New York、New York、アメリカ、10029
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
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Durham、North Carolina、アメリカ、27710
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Ohio
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Cincinnati、Ohio、アメリカ、45267
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Oregon
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Portland、Oregon、アメリカ、97239
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Pennsylvania
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Danville、Pennsylvania、アメリカ、17822
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Harrisburg、Pennsylvania、アメリカ、17105
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South Carolina
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Charleston、South Carolina、アメリカ、29425
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Texas
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San Antonio、Texas、アメリカ、78229
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Utah
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Salt Lake City、Utah、アメリカ、84132
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Wisconsin
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Madison、Wisconsin、アメリカ、53792
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Milwaukee、Wisconsin、アメリカ、53226
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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:
- Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-human leukocyte antigen (HLA) living donor kidney (ie., HLA identical or 0 antigen mismatch deceased donor kidneys are allowed).
Exclusion Criteria:
- Patient has previously received an organ transplant other than a kidney
- Patient receiving chronic steroid therapy at time of transplant
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：Alemtuzumab High-Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
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オーラル
他の名前：
オーラル
他の名前：
Intravenous (IV)
他の名前：
IV and/or oral
|
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アクティブコンパレータ：Conventional High-Risk Patients
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
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オーラル
他の名前：
オーラル
他の名前：
IV and/or oral
IV
他の名前：
|
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実験的：Alemtuzumab Low- Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
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オーラル
他の名前：
オーラル
他の名前：
Intravenous (IV)
他の名前：
IV and/or oral
|
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アクティブコンパレータ：Conventional Low-Risk Patients
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
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オーラル
他の名前：
オーラル
他の名前：
IV and/or oral
IV
他の名前：
|
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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Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months
時間枠：6 months
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A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) & Severe (3). Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st. |
6 months
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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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Overall Patient Incidence of BCAR
時間枠：End of Study (36 months)
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Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A & 1B) to Moderate (2A & 2B) to Severe (3). End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
End of Study (36 months)
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Efficacy Failure
時間枠：End of Study (36 months)
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Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
End of Study (36 months)
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Clinically Treated Acute Rejection
時間枠：End of Study (36 months)
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Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
End of Study (36 months)
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Time to First BCAR
時間枠：End of Study (36 months)
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Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
End of Study (36 months)
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Graft Survival at 12 Months
時間枠：12 months
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Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure. Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first. |
12 months
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Overall Graft Survival
時間枠：End of Study (36 months)
|
Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
End of Study (36 months)
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Patient Survival at 12 Months
時間枠：12 months
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Patient survival is defined as not dead within 12 months after skin closure. Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first. |
12 months
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Overall Patient Survival
時間枠：End of Study (36 months)
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Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
End of Study (36 months)
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Renal Function Abnormalities Based on Creatinine Clearance
時間枠：1 month and End of Study (36 months)
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Increases in creatinine clearance usually indicates an improvement. Change in creatinine clearance from month 1 was calculated. Change from 1 month is calculated by month 36 - month 1. |
1 month and End of Study (36 months)
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Renal Function Abnormalities Based on Serum Creatinine
時間枠：1 month and End of Study (36 months)
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Decrease in serum creatinine usually indicates an improvement. Change in creatinine clearance from month 1 was calculated. Change from 1 month is calculated by month 36 - month 1. |
1 month and End of Study (36 months)
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Central Contact、Astellas Pharma Global Development
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
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。