Trial of Steroid Avoidance and Low-dose CNI by ATG-induction in Renal Transplantation (SAILOR)
A Controlled Randomized, Open-label, Multi-centre Study Evaluating if a Steroid-free Immunosuppressive Protocol, Based ATG-induction, Low Tacrolimus-dose and Therapeutic Drug Monitoring of Mycophenolate Mofetil, Reduces the Incidence of New Onset Diabetes After Transplantations, in Comparison With Standard Steroid-based Protocol With Low-dose Tacrolimus.
Balancing immunosuppressive treatment in organ transplantation in order to achieve effective prevention of rejection on one side and avoidance of negative side effects on the other side is a major challenge, leading to developing different immunosuppressive protocols. Cornerstones of immunosuppressive treatment such as Corticosteroids (CS) and Calcineurin Inhibitors (CNI) are known to cause an increased incidence of diabetes, cardiovascular morbidity, nephrotoxicity and malignancies.
The investigators believe that both avoidance of CS and minimization of CNI, while using Anti-ThymocyteGlobuline(ATG) induction (instead of interleucin-2 receptor blockers) and mycofenolate mofetil(MMF) therapeutic drug monitoring is going to reduce negative side effects, without increased rejection frequency in renal transplanted patients.
調査の概要
状態
条件
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
-
-
-
Gothenburg、スウェーデン、41345
- Transplant Institute, Sahlgrenska University Hospital
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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:
- First or second single kidney (cadaveric or living donors) transplant recipients.
- Considered for a standard immunosuppressive protocol.
- Must be capable of giving written informed connect for participation in the study for 24 months.
Exclusion Criteria:
- Diabetes mellitus or plasma glucose >11,1 at admission.
- Receiving steroids at the time of transplantation or likely to need steroids after transplantation.
- Multiorgan transplants and/or previously transplanted with any other organ than kidney.
- Panel reacting antibodies(PRA) >25% in most recent test or considered to be of high risk for rejection which requires an enhanced immunosuppression.
- Renal transplants from HLA-identical sibling.
- Hypersensitivity to, or disability to take immunosuppressive drugs.
- Blood group(ABO)-incompatible transplants.
- Unlikely to comply with the study requirements.
- Transplant from donor positive for HIV, HBsAg, Hepatitis C.
- Female of childbearing potential planing/being pregnant or unwilling to use contraception.
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 |
|---|---|
|
実験的：Steroid-free low TAC-arm
Induction therapy: Thymoglobulin i.v. 2,5 mg/kg day 0 and 1, preceded by methylprednisolone i.v. 250 mg day 0 and 50 mg day 1. Maintenance therapy: Advagraf(TAC) 0,2 mg/kg p.o. started day1 (target concentration 5-10 ng/ml, after 3 months 4-7 ng/ml; MMF 1g x 2 p.o. (target Area Under Curve, AUC 40-60 mg.h/L); No steroids p.o. |
|
|
アクティブコンパレータ：Standard low-TAC arm
Induction therapy: Simulect i.v. 20 mg day 0 and 4; Steroids i.v. according to local practice. Maintenance therapy: Advagraf(TAC) p.o. 0,2 mg/(target concentration 5-10 ng/ml, after 3 months 4-7 ng/ml); MMF 1g x 2 p.o. (target AUC 40-60 mg.h/L); Steroids p.o. according to hospital practice (but not less than 5mg daily after 6 months). |
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 |
時間枠 |
|---|---|
|
Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT)
時間枠：12 month after transplantation
|
12 month after transplantation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cumulative incidence of NODAT
時間枠：3, 6, 24 month after transplantation
|
3, 6, 24 month after transplantation
|
|
|
Composite measure
時間枠：12, 24 months
|
Freedom from acute rejection, graft and patient survival
|
12, 24 months
|
|
Renal function
時間枠：12, 24 months
|
Evaluated by measured glomerular filtration rate (mGFR)
|
12, 24 months
|
|
Incidence of acute rejection and chronic changes
時間枠：12 months
|
Analysed by protocol biopsies, evaluated by the Banff system.
|
12 months
|
|
Incidence of hypertension
時間枠：3, 12, 24 months
|
Standardized measurement.
|
3, 12, 24 months
|
|
Antihypertensive treatment
時間枠：3, 12, 24 months
|
Number and type of antihypertensive drugs.
|
3, 12, 24 months
|
|
Lipid lowering drugs
時間枠：12, 24 months
|
Number and type of lipid lowering drugs.
|
12, 24 months
|
|
Incidence of antibody-mediated rejection
時間枠：12, 24 months
|
Analysed by biopsies, evaluated by the Banff system, and by donor-specific HLA antibodies
|
12, 24 months
|
|
Cumulative frequency of cardiovascular complications and events.
時間枠：10 days, 3, 12, 24 months
|
Collecting Adverse Events (AE) reports
|
10 days, 3, 12, 24 months
|
|
Cumulative frequency of malignancy.
時間枠：6, 12, 24 months
|
Collecting AE reports
|
6, 12, 24 months
|
|
Cumulative frequency of infections
時間枠：10 days, 3, 6, 12, 24 months
|
Collecting AE reports
|
10 days, 3, 6, 12, 24 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Per Lindnér, MD、Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
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
- 2012-000451-13
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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