2023-506879-98-00招募中4 期
A multi-centre, open, prospective, randomized, parallel-group, 24-month study to compare the outcome of receiving continued immunosuppression versus stopping immunosuppression at 6 months to safely prevent human leukocyte antigen (HLA) sensitization in patients with late renal graft failure
Vall D'hebron Institut De Recerca, Vall D'hebron Institut De Recerca6 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2023年11月10日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 202
- 试验地点
- 6
- 主要终点
- The primary variable will be the difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%).
研究概览
简要总结
To compare the degree of HLA sensitization at 2 years in patients with late renal graft failure (> 3 months) when receiving reduced immunosuppressant treatment versus stopping immunosuppression at 6 months.
研究设计
- 分配方式
- Randomized
- 主要目的
- Prevsensi
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for the study must comply with all of the following at randomization; Patient must be able to understand and provide written informed consent; Patients older than 18 years who had received at least one previous renal transplant; Patients with a retained kidney graft failed for any reason which survived at least 3 months; Patients on dialysis, either hemodialysis or peritoneal dialysis. Patients can be on dialysis for a maximum of 6 months at the time of randomization, as long as the patients have taken an uninterrupted immunosuppressive regimen of calcineurin inhibitors (tacrolimus or cyclosporine) and steroids since dialysis was restarted; Patients already relisted or candidates to relist to deceased donor kidney transplantation according to the treating physician criteria; Patients taking immunosuppressants tacrolimus or cyclosporine; cPRA at the time of randomization ≤ 90%.
排除标准
- •The following patients will be excluded from the study: Patients who have received another solid organ transplantation (liver, lung, heart or pancreas); Patients waiting for a living related / unrelated kidney transplant; Graft survival of the failed graft lower than 3 months; Patients in dialysis more than 6 months at the time of randomization; Patients not accomplishing criteria to relist in the transplantation list according to the treating physician criteria; Pregnant women; • Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study; Patients should use one of the acceptable birth control measures recommended in the document “Recommendations related to contraception and pregnancy testing in clinical trials” published by the Clinical Trials Facilitation and Coordination Group (CTFG) (version 1.1, published 21/09/2020). Recommended birth control measures include oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, or sexual abstinence. If sexually active, the subject must have been using one of the accepted birth control methods at least one month prior to study entry
结局指标
主要结局
The primary variable will be the difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%).
The primary variable will be the difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%).
次要结局
未报告次要终点
研究者
Laura Cascales
Scientific
Vall D'hebron Institut De Recerca
研究点 (6)
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