A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipient
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 主要终点
- Change in Glomerular Filtration Rate (GFR) Change From Baseline
研究概览
简要总结
This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce the severity and/or progression of chronic allograft nephropathy (CAN).
详细描述
This open-label, randomized, parallel-group, comparative, outpatient study will be conducted in multiple centers in Taiwan.
The study will randomize approximately 120 patients. 80 patients will be randomized to the SRL therapy group (conversion from CI- to SRL-based immunosuppression: group A) and 40 patients to the CI therapy group (continued CI therapy: group B).
Dosage and Administration
SRL Therapy: At the time of randomization on day 1, each patient will have been receiving:
- triple therapy with a CI (tacrolimus or CsA) that began at the time of transplantation or within 2 weeks thereafter AND
- corticosteroids corresponding to a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent for at least 12 weeks before randomization, PLUS
- either MMF (minimum dose 500 mg/day)/MPS (minimum dose 360 mg/day) or AZA (minimum dose 50 mg/day) for at least 12 weeks before randomization.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be at least 18 years of age.
- •Subjects who are 6 to 60 months after renal transplantation.
- •Subjects who have a stable graft function.
排除标准
- •Subjects with active major infection, including HIV, decreased platelets, elevated lipids, or multiple organ transplants.
研究组 & 干预措施
1
Sirolimus therapy
干预措施: Sirolimus+MMF or MPS or AZA+Steroid (Drug)
2
Calcineurin Inhibitor therapy (either cyclosporine or tacrolimus)
干预措施: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid (Drug)
结局指标
主要结局
Change in Glomerular Filtration Rate (GFR) Change From Baseline
时间窗: 104 weeks
GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR \<15 is consistent with kidney failure.
次要结局
- Change From Baseline in Diastolic Blood Pressure at Week 24(Baseline and Week 24)
- Change From Baseline in Systolic Blood Pressure at Week 24(Baseline and Week 24)
- Change From Baseline in Systolic Blood Pressure at Week 52(Baseline and Week 52)
- Change in Glomerular Filtration Rate (GFR)(Baseline and Week 104)
- Patient and Graft Survival(Week 104)
- Change From Baseline in Diastolic Blood Pressure at Week 52(Baseline and Week 52)
- Change From Baseline in Diastolic Blood Pressure at Week 104(Baseline and Week 104)
- Change From Baseline in Systolic Blood Pressure at Week 104(Baseline and Week 104)
- Change From Baseline in the Severity and Progression of Biopsy-Confirmed Chronic Allograft Nephropathy (CAN) at Week 104(Baseline and Week 104)
- Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 52(Weeks 52)
- Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 104(Week 104)
- Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 24(Week 24)
- Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 52(Week 52)
- Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 104(Week 104)