NCT01492894撤回4 期
A Randomized Controlled Trial of Reducing Calcineruin Inhibitor Target Level by 50% Versus Converting to Rapamycin in Chronic Kidney Dysfunction Without Reversible Causes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Kidney function will be determined by the rate of change in glomerular filtration rate (GFR), estimated by serum creatinine (eGFR).
研究概览
简要总结
The purpose of this study is to learn the best way to prolong kidney life in patients exposed to calcineurin inhibitors, who already have evidence of damage possibly caused by the calcineurin inhibitor on kidney biopsy.
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
- •Serum creatinine increased greater than or equal to 25% over baseline with no acute or reversible cause clinically evident.
- •Although eGFR is arguably better for estimating kidney allograft function than serum creatinine, pragmatics dictate the use of a change in serum creatinine in the initial selection of patients. These criteria are currently used by transplant coordinators for selection of patients for the kidney biopsy as a part of large on-going study at our center.
- •Adequate (greater than or equal to 8 glomeruli) biopsy showing Chronic allograft injury reported as mild/moderate CAN or CNI toxicity based on the previously used Banff 97 classification and no potentially reversible causes of graft dysfunction, e.g. acute rejection or treatable recurrent disease. Patients with histological evidence of mild recurrent disease that does not appear to be severe enough to explain the deterioration in function, e.g. IgA on immunofluorescence, or changes consistent with early diabetic nephropathy, will not be excluded.
- •Receiving CsA (trough level concentration 75-125 ng/mL) or Tacrolimus(trough level concentration 6-12 ng/mL) plus MMF (or AZA) with (or without) prednisone.
- •Able to give informed consent.
排除标准
- •Urine total protein excretion >500 mg/g creatinine.
- •eGFR (estimated by MDRD) <40 mL/min/1.73 m2
- •Triglycerides >400 mg/dL or total cholesterol >300 mg/dL
- •Allergy to macrolide antibiotic or rapamycin
- •Women of child-bearing potential not using effective contraception
- •Treated for acute rejection within the past 2 months
- •<12 months after transplantation
- •Potentially treatable cause(s) of allograft dysfunction, including acute rejection, dehydration, and congestive heart failure.
- •Recurrent or de novo kidney disease that is histologically severe enough to be causing graft dysfunction
- •Polyoma virus (BK) nephropathy, or serum positive for BK by polymerase chain reaction
- •A second, functioning organ transplant.
- •Receiving sirolimus.
- •Patients with any past or present malignancy (other than non-melanoma skin cancer)
研究组 & 干预措施
50% decrease in calcineurin inhibitor
Active Comparator
干预措施: Cyclosporins/Tacrolimus (Drug)
Rapamune
Active Comparator
干预措施: Sirolimus (Drug)
结局指标
主要结局
Kidney function will be determined by the rate of change in glomerular filtration rate (GFR), estimated by serum creatinine (eGFR).
时间窗: Once a week for 3 month then monthly until trial ends
次要结局
未报告次要终点
研究者
研究点 (1)
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