Multicentre, Prospective, Randomized, Open-label Study Comparing the Efficacy and Safety of CellCept With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Standard Immunosuppression Comprising CellCept and Long-term Continuation of Cyclosporine in Renal Transplant Recipients Receiving Induction by Zenapax and Treated With Corticosteroids for 8 Months
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 237
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This multicentre, prospective, randomized, open-label study will compare the safety and efficacy of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation of cyclosporine, with those of mycophenolate mofetil and long term continuation of cyclosporine in renal transplant recipients receiving daclizumab (Zenapax) as induction treatment and followed by 8 month treatment with corticosteroids. The anticipated time on study treatment is 12 months. Participants who will complete the initial 12-month study and who will provide written informed consent will be eligible to participate in a 60-month follow-up phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receipt of a first cadaveric kidney graft
- •Antilymphocyte antibodies and panel reactive antibodies (PRA) less than 30 percent (%) (historical peak and/or current value)
- •Cold ischaemia time less than or equal to 36 hours
排除标准
- •Kidney from a living donor; donor greater than (>) 65 years of age; second renal graft, or more; or multiple organ transplant
- •Known hypersensitivity to any of the drugs in the study or their components
- •History of cancer or malignancy during previous 5 years, other than successfully treated spinocellular or basal cell cancer
- •Participant presenting, on inclusion, either symptoms suggestive of active gastroduodenal ulcer, or gastroduodenal ulcer confirmed by fibroscopy and biopsy, and requiring treatment
- •Participant with severe refractory hyperlipidaemia
- •Pregnant woman or nursing mother
- •Exclusion Criteria for Follow-up Phase:
- •Episode of acute rejection greater than or equal to grade I (Banff classification)
- •Estimated creatinine clearance (CrCl) at week 12 less than (<) 40 milliliter per minute (mL/min) (Cockcroft-Gault formula)
- •Serum creatinine variations >30% during the 15 days before randomization
- •Proteinuria >1 gram/24 hour, or mean mycophenolate mofetil dose < 1.5 gram/day during the week before randomization
研究组 & 干预措施
Mycophenolate Mofetil + Cyclosporine
Participants will receive mycophenoate mofetil, daclizumab, cyclosporine, and corticosteroids (prednisolone) for 3 to 12 months.
干预措施: Cyclosporine (Drug)
Mycophenolate Mofetil + Cyclosporine
Participants will receive mycophenoate mofetil, daclizumab, cyclosporine, and corticosteroids (prednisolone) for 3 to 12 months.
干预措施: Daclizumab (Drug)
Mycophenolate Mofetil + Cyclosporine
Participants will receive mycophenoate mofetil, daclizumab, cyclosporine, and corticosteroids (prednisolone) for 3 to 12 months.
干预措施: Mycophenoate Mofetil (Drug)
Mycophenolate Mofetil + Cyclosporine
Participants will receive mycophenoate mofetil, daclizumab, cyclosporine, and corticosteroids (prednisolone) for 3 to 12 months.
干预措施: Prednisolone (Drug)
Mycophenolate Mofetil + Sirolimus
Participants will receive mycophenoate mofetil, daclizumab, and corticosteroids (prednisolone) for 3 to 12 months. Participants will also receive cyclosporine which will be replaced with sirolimus at later stage of the study.
干预措施: Cyclosporine (Drug)
Mycophenolate Mofetil + Sirolimus
Participants will receive mycophenoate mofetil, daclizumab, and corticosteroids (prednisolone) for 3 to 12 months. Participants will also receive cyclosporine which will be replaced with sirolimus at later stage of the study.
干预措施: Daclizumab (Drug)
Mycophenolate Mofetil + Sirolimus
Participants will receive mycophenoate mofetil, daclizumab, and corticosteroids (prednisolone) for 3 to 12 months. Participants will also receive cyclosporine which will be replaced with sirolimus at later stage of the study.
干预措施: Mycophenoate Mofetil (Drug)
Mycophenolate Mofetil + Sirolimus
Participants will receive mycophenoate mofetil, daclizumab, and corticosteroids (prednisolone) for 3 to 12 months. Participants will also receive cyclosporine which will be replaced with sirolimus at later stage of the study.
干预措施: Prednisolone (Drug)
Mycophenolate Mofetil + Sirolimus
Participants will receive mycophenoate mofetil, daclizumab, and corticosteroids (prednisolone) for 3 to 12 months. Participants will also receive cyclosporine which will be replaced with sirolimus at later stage of the study.
干预措施: Sirolimus (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to approximately 12 months
Creatinine Clearance Calculated and Corrected According to Cockcroft Gault at Week 52
时间窗: 52 weeks
Creatinine Clearance Calculated and Corrected According to Cockcroft Gault at Month 60
时间窗: 60 months
Number of Participants With Serious Adverse Events (SAEs)
时间窗: From 12 months up to 60 months
Number of Participants With Cancers and Lymphoproliferative Syndromes
时间窗: Up to approximately 12 months
Number of Participants With Premature Discontinuations due to Adverse Events (AEs)
时间窗: Up to approximately 12 months
Change From Baseline in 24-Hour Urinary Protein at Week 52
时间窗: 52 weeks
次要结局
- Mean Inverse Creatinine Concentration(Week 4, 8, 12, 14, 16, 26, 39, and 52)
- Number of Participants With Biopsy-proven Acute Rejections(Baseline up to Month 60)
- Number of Participants Who Were Alive(Month 60)
- Mean Serum Creatinine Concentration(Week 4, 8, 12, 14, 16, 26, 39, and 52)
- Number of Participants With Histologic Evaluation of the Graft(Week 52)
- Creatinine Clearance Calculated and Corrected According to Cockcroft-Gault(Week 4, 8, 12, 14, 16, 26, 39, and 52)
- Number of Participants with Response to Treatment, Defined as Creatinine Clearance >/=60 mL/min at Week 52(Week 52)
- Glomerular Filtration Rate (GFR) Measured by Iohexol Clearance(Baseline, Week 52)
- Number of Participants With Treated Rejections(Baseline up to Week 52)
- Number of Participants With Graft Survival(Month 60)