The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 主要终点
- The incidence of interstitial fibrosis/tubular atrophy as defined by Banff interstitial and tubular chronic changes of ci + ct of 2 or more at 6 months
研究概览
简要总结
This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.
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
- •Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant
- •If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods
排除标准
- •Recipients of a kidney from a donor over 65 years of age
- •Recipient of non-related donor kidney with peak pre-transplant PRA > 50
- •Subject has lost a previous graft to rejection less than one year from transplant
- •Subject who has received an investigational drug within three months prior to randomization
- •Subjects who are pregnant or breastfeeding
- •Subject receives a kidney lacking a pre-implantation biopsy
- •Subject has significant disease or disability (e.g. malignancy or uncontrolled infection) which prevents adherence to the protocol
研究组 & 干预措施
1
Protocol biopsies at 1, 2 and 3 months
干预措施: Tacrolimus (Drug)
1
Protocol biopsies at 1, 2 and 3 months
干预措施: MMF (Drug)
1
Protocol biopsies at 1, 2 and 3 months
干预措施: Corticosteroids (Prednisone) (Drug)
2
No protocol biopsies
干预措施: Tacrolimus (Drug)
2
No protocol biopsies
干预措施: MMF (Drug)
2
No protocol biopsies
干预措施: Corticosteroids (Prednisone) (Drug)
结局指标
主要结局
The incidence of interstitial fibrosis/tubular atrophy as defined by Banff interstitial and tubular chronic changes of ci + ct of 2 or more at 6 months
时间窗: 6 months
次要结局
- The incidence of subclinical rejection at 6 months(6 months)
- Prevalence of chronic renal histopathology at 24 months(24 months)
- Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion(6, 12 and 24 moths)