Protocol Calcineurin Inhibitor (CNI) Weaning
2016年3月22日 更新者:Nantes University Hospital
Prospective, Multicenter, Randomized, Double-blind, Controlled Parallel Group Study Designed to Assess the Risk-benefit Balance of the Gradual Withdrawal of a Calcineurin Inhibitor (Tacrolimus) in Renal Transplant Patients Over 4 Years and Clinically Selected
The main objective of this study is to demonstrate the benefit of the withdrawal of Tacrolimus (Prograf®) on renal function in patients one year after the end of the weaning period.
The secondary objectives will focus on assessing the risks and consequences of withdrawal of Tacrolimus (Prograf®).
調査の概要
研究の種類
介入
入学 (実際)
16
段階
- フェーズ 3
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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-
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Nantes、フランス、44093
- Nantes University Hospital
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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~80年 (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
Pre-inclusion criteria :
- Male or female aged between 18 and 80 years (inclusive),
- Having received a deceased donor transplant or living with ABO compatibility,
- First renal allograft for at least 4 years and under 10 years,
- Presenting a stable renal function : serum creatinine with a variation of ± 25% of the average of the year before inclusion,
- Treated with tacrolimus (Prograf®) in combination with MPA (Cellcept® and Myfortic®) + / - steroids (between 5 and 10 mg per day),
- Patient has given informed consent,
- Patient insured,
- Patient (of childbearing age) with effective contraception.
Inclusion Criteria:
- Glomerular Filtration Rate (GFR), defined by the dosage of cystatin C ≥ 40 ml/min/1, 73m²,
- Proteinuria ≤ 0,5 g / day,
- Patient with serum levels of Tacrolimus between 5 to 10 ng / ml on average during the last 6 months (inclusive). It is accepted that 25% of the assays performed during the last 6 months, serum levels of tacrolimus are outside the limits mentioned above (5-10 ng / ml). They must nevertheless be between 3.5 to 12.5 ng / ml (inclusive).
- Patient with serum levels of MPA (Cellcept® and Myfortic®) higher ≥ 30 mg / ml,
- No anti-HLA antibodies at the time of inclusion, verified using highly sensitive techniques (Luminex HD),
- Lack of histological evidence of cellular or humoral acute or chronic or subclinical rejection on renal graft according to the latest classification of Banff 2009.
Exclusion Criteria:
- Patients under age 18 or over 80 years,
- Transplanted from less than 4 years and over 10 years,
- Patients re-transplanted,
- Transplantation of several organs,
- Patient not treated with tacrolimus as maintenance therapy,
- Serum levels of Tacrolimus patient <5 or >10 ng / ml,
- Serum levels of MPA of the patient <30 mg / ml,
- Patients treated with other immunosuppressive drugs that Tacrolimus (Prograf®), MPA (Cellcept® and Myfortic®) and steroids,
- Patient not having a stable graft function at baseline (change in serum creatinine > 25% of the average of the year before inclusion in the study), with a GFR defined by the dosage of cystatin C <40 ml/min/1, 73m² at the time of inclusion,- Patients with proteinuria > 0.5 g at study entry,
- Patient with HLA antibodies at study entry,
- Patient non-compliant,
- Presence of histological evidence of cellular or humoral acute or chronic or subclinical rejection on renal graft according to the latest classification of Banff 2009,
- History of lymphoproliferative disorders,
- Diagnosis of a malignancy within 5 years before enrollment,
- Significantly abnormal hematologic data of a clinical standpoint, as determined by the investigator for hematocrit, hemoglobin, white blood cell count or platelets,
- Data significantly abnormal blood biochemistry of a clinical standpoint, as determined by the investigator,
- Abuse of significant drug or alcohol at the time of inclusion, determined by the investigator,
- Patient positive for antibodies to hepatitis C or hepatitis B surface antigen of hepatitis B (HBsAg) or HIV infection,
- Participation in a clinical study within 3 months,
- Pregnancy, Breastfeeding.
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:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:Tacrolimus
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A control group continued conventional therapy, Tacrolimus (Prograf®) ("control" group) and will be followed in parallel group "withdrawal" that will stop treatment with Tacrolimus (Prograf®).
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実験的:Withdrawal of Tacrolimus
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Patients randomized to the "withdrawal"group will begin the protocol with their usual dose of Tacrolimus (Prograf®) (initial dose).
The initial dose of tacrolimus (Prograf®) will be reduced by one third at visit 3 (day 0) and again a third visit 5 (J60).
The complete withdrawal Tacrolimus (Prograf®) begins to visit 7 (J120).
The withdrawal of Tacrolimus (Prograf®) will be obtained in four months.
Monitoring of all patients lasted 17 months in total from the screening visit, which corresponds to 12 months after complete withdrawal of Tacrolimus (Prograf®) for patients in the "withdrawal" group.
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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 |
---|---|---|
Renal function
時間枠:one year after complete withdrawal of Tacrolimus
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The primary endpoint will be the improvement of renal function one year after complete withdrawal of Tacrolimus (Prograf®) assessed by measuring the glomerular filtration rate (GFR) calculated by the dosage of cystatin C according to the equation Bricon.
The DFG will be compared between times J-30 and J480 (1 year after the withdrawal).
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one year after complete withdrawal of Tacrolimus
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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 |
---|---|---|
Renal function
時間枠:one year after complete withdrawal
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Improvement of renal function by measuring serum creatinine, using the original MDRD equation,
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one year after complete withdrawal
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Acute rejection
時間枠:one year after complete withdrawal
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Rate of histologically proven acute rejection by biopsy according to Banff classification 2009,
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one year after complete withdrawal
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Chronic rejection
時間枠:One year after complete withdrawal
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Rate of chronic rejection histologically proven by biopsy according to Banff classification 2009,
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One year after complete withdrawal
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Steroid-resistant rejection
時間枠:One year after complete withdrawal
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Rates of steroid-resistant rejection
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One year after complete withdrawal
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Graft survival
時間枠:One year after complete withdrawal
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Rate of return to dialysis (graft survival)
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One year after complete withdrawal
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Cancer and infections
時間枠:one year after complete withdrawal
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Incidence of cancer and infections
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one year after complete withdrawal
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Patients survival
時間枠:One year after complete withdrawal
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Survival rate of patients
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One year after complete withdrawal
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Anti-HLA antibodies
時間枠:One year after complete withdrawal
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Appearance of anti-HLA donor specific and non-donor specific antibodies measured by the technique Luminex
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One year after complete withdrawal
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Histological lesions of rejection
時間枠:One year after complete withdrawal
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The appearance of histological lesions of cellular or humoral acute or chronic or subclinical rejection on the biopsy protocol
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One year after complete withdrawal
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Histological lesions of fibrosis
時間枠:One year after complete withdrawal
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Onset or worsening of histological lesions of interstitial fibrosis and tubular atrophy on biopsy inflammatory
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One year after complete withdrawal
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Hypertension, hyperglycemia and hyperlipidemia
時間枠:One year after complete withdrawal
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Incidence of hypertension, hyperglycemia and hyperlipidemia
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One year after complete withdrawal
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Quality of life
時間枠:One year after complete withdrawal
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Determination of the benefits of withdrawal of Tacrolimus on the quality of life of patients, defined by the scale of quality of life validated SF-36 used at the beginning (J-15) and at the end of the weaning period (J120) at 6 months (J300) and one year after complete withdrawal of Tacrolimus (J480)
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One year after complete withdrawal
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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。
捜査官
- スタディチェア:Emmanuel MORELON, Profesor、Chu de Lyon
- 主任研究者:Magali GIRAL, Profesor、CHU de Nantes
- スタディチェア:Jean-Paul SOULILLOU, Profesor、CHU de Nantes
- スタディチェア:Christophe LEGENDRE, Profesor、Hôpital Necker - AP-HP
- スタディチェア:Georges MOURAD, Profesor、CHU de Montpellier
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
2011年5月1日
一次修了 (実際)
2015年5月1日
研究の完了 (実際)
2015年5月1日
試験登録日
最初に提出
2011年2月8日
QC基準を満たした最初の提出物
2011年2月8日
最初の投稿 (見積もり)
2011年2月9日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年3月23日
QC基準を満たした最後の更新が送信されました
2016年3月22日
最終確認日
2015年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 09/7-D
- 2010-019574-33 (EudraCT番号)
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。