临床试验/NCT01363752

NCT01363752

已完成

4 期

A Multicenter, Two Arm, Randomized, Open Label Clinical Study Investigating Renal Function in an Advagraf® Based Immunosuppressive Regimen With or Without Sirolimus in Kidney Transplant Patients

Astellas Pharma Inc58 个研究点分布在 15 个国家目标入组 853 人2011年3月8日

适应症Kidney Transplantation

干预措施Corticosteroids Advagraf Mycophenolate Mofetil Sirolimus

概览

阶段: 4 期
干预措施: Corticosteroids
疾病 / 适应症: Kidney Transplantation
发起方: Astellas Pharma Inc
入组人数: 853
试验地点: 58
主要终点: Glomerular Filtration Rate (GFR) estimated by iohexol clearance at Week 52 post kidney transplantation
状态: 已完成
最后更新: 去年

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.

详细描述

This study will evaluate the potential to reduce nephrotoxic calcineurin inhibitors (CNI) therapy by lowering tacrolimus exposure from Advagraf® in combination with the non-nephrotoxic immunosuppressant sirolimus to avoid the risk of acute graft rejection, compared with an Advagraf® and Mycophenolate Mofetil (MMF) immunosuppressive regimen.

注册库

clinicaltrials.gov

开始日期

2011年3月8日

结束日期

2013年9月18日

最后更新

去年

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Astellas Pharma Inc

责任方

Sponsor

入排标准

入选标准

•End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 6 months)
•Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen \[HLA\] identical) donor with compatible ABO blood type
•Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment
•Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/ 286/ 95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner

排除标准

•Receiving or having previously received an organ transplant other than a kidney
•Cold ischemia time of the donor kidney \> 30 hours
•Panel Reactive Antibody (PRA) \>20%
•Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest)
•Significant liver disease, defined as having continuously elevated SGPT/ ALT and/ or SGOT/ AST and/ or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
•Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
•Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy)
•Significant, uncontrolled concomitant infections and/ or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
•Pregnant woman or breast-feeding mother
•Subject or donor known to be HIV positive

研究组 & 干预措施

Advagraf + MMF + Steroids + Sirolimus

With sirolimus; MMF withdrawn on Day 28; Sirolimus introduced on Day 28

干预措施: Corticosteroids

Advagraf + MMF + Steroids

Without sirolimus

干预措施: Advagraf

Advagraf + MMF + Steroids

Without sirolimus

干预措施: Mycophenolate Mofetil

Advagraf + MMF + Steroids

Without sirolimus

干预措施: Corticosteroids

Advagraf + MMF + Steroids + Sirolimus

With sirolimus; MMF withdrawn on Day 28; Sirolimus introduced on Day 28

干预措施: Advagraf

Advagraf + MMF + Steroids + Sirolimus

With sirolimus; MMF withdrawn on Day 28; Sirolimus introduced on Day 28

干预措施: Mycophenolate Mofetil

Advagraf + MMF + Steroids + Sirolimus

With sirolimus; MMF withdrawn on Day 28; Sirolimus introduced on Day 28

干预措施: Sirolimus

结局指标

主要结局

Glomerular Filtration Rate (GFR) estimated by iohexol clearance at Week 52 post kidney transplantation

时间窗: up to 1 year

次要结局

GFR at Week 52 post kidney transplantation by Modification Diet in Renal Disease (MDRD) formula(up to 1 year)
GFR at Week 52 post kidney transplantation by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula(up to 1 year)
Calculated creatinine clearance at Week 52 post kidney transplantation by Cockcroft and Gault formula(up to 1 year)
Incidence of clinical acute rejection(up to 1 year)
Subject survival(up to 1 year)
Efficacy failure(up to 1 year)
New Onset Diabetes Mellitus (NODM) as per American Diabetic Association (ADA) criteria(up to 1 year)
Time to clinical acute rejection(up to 1 year)
Incidence of Biopsy Confirmed Acute Rejection(up to 1 year)
Time to Biopsy Confirmed Acute Rejection(up to 1 year)
Graft survival(up to 1 year)