NCT02490904进行中（未招募）3 期
Double-blind Placebo-Controlled Randomized Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenone After Renal Transplantation : Effect on Graft Function at 3 Months.
Central Hospital, Nancy, France7 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2016年10月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
- 试验地点
- 7
- 主要终点
- Iohexol clearance
研究概览
简要总结
Assess the impact of eplerenone (initiated within 2 hours prior to patient departure to the operating room and administered for 4 days during the post-operative period) on graft function evaluated by the measurement of glomerular filtration rate at 3 months - variable strongly associated with long-term graft survival.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients older than 18 years of age
- •Informed consent
- •Candidate for a single or a dual kidney transplantation from an expanded criteria deceased donor ( 60 years or older or age between 50 and 59 with 2 of the 3 following criteria: cardiovascular death, history of hypertension, serum creatinine above 130µmol/L), regardless of machine perfusion and graft rank
- •Chronic hemodialysis
- •Affiliated to a social security system
排除标准
- •Multiple organ transplantation (kidney and liver, kidney and heart, kidney and pancreas, kidney and lung, kidney and intestine)
- •Patient receiving a graft from a donor under mineralocorticoid receptor antagonist treatment (spironolactone or eplerenone)
- •Peritoneal dialysis
- •Preemptive transplantation
- •Hypersensitivity or known allergy to Eplerenone or one of its excipients
- •Patients with severe hepatic insufficiency (class Child-Pugh C)
- •Patient receiving powerful CYP3A4 inhibitors (for example itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycyn and nefazodone)
- •Hypersensitivity or known allergy to iodinated contrast agents (iohexol)
- •Demonstrated thyrotoxicosis
- •Hypersensitivity to lactose
- •HLA desensitization prior to renal transplantation
- •Pregnant woman or woman without effective contraception
- •Patient under judicial protection
- •Patient under legal guardianship
- •Participation in another biomedical study
研究组 & 干预措施
Eplerenone group
Experimental
Eplerenone administration within 2 hours prior to patient departure to the operating room and for 4 days after kidney transplantation.
干预措施: Eplerenone (Drug)
Placebo group
Placebo Comparator
Placebo administration within 2 hours prior to patient departure to the operatingroom and for 4 days after kidney transplantation
干预措施: Placebo (Drug)
结局指标
主要结局
Iohexol clearance
时间窗: 3 months
Graft function at 3 months evaluated by GFR using iohexol clearance
次要结局
- 24-hour microalbuminuria(3 months)
- Length of initial hospital stay(1 month)
- Proportion of patients with biopsy-proven acute rejection(3 months post transplant)
- glomerular filtration rate(3 months 1 year, 3 years, 10 years)
- Proportion of patients presenting a delayed graft function(7 days post transplantation)
- 24-hour proteinuria(3 months)
- Occurrence of hyperkalemia > 6 mmol/l(7 days post transplant)
- Proportion of patients alive(3 months 1 year, 3 years, 10 years)
- Proportion of patients with immediate renal recovery,(7 days post transplant)
- Proportion of dialysis dependency(3 months)
- serum creatinine(3 months 1 year, 3 years, 10 years)
- Iohexol clearance < 30 mL/min/1,73m²(3 months)
- Proportion of patients with a slow renal recovery(7 days post transplant)
研究者
Pr. Nicolas GIRERD
Study chair
Central Hospital, Nancy, France
研究点 (7)
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