NCT03689075终止4 期
Study to Compare Once-daily Extended Release Tacrolimus Versus Twice-daily Immediate Release Tacrolimus Following Renal Allograft Failure to Reduce the Risk of Allosensitisation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Incidence of de novo allosensitisation (donor specific antibodies) at 24 months post allograft failure.
研究概览
简要总结
Study to compare once-daily extended release tacrolimus versus twice-daily immediate release tacrolimus following renal allograft failure to reduce the risk of allosensitisation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Able to give informed consent.
- •Male or female, at least 18 years of age.
- •Has renal allograft failure and is due to start haemodialysis therapy or within 28 days following starting dialysis.
- •Has been already activated on the transplant wait list or is undergoing work up to be reactivated on the transplant list.
- •Has no indication for graft nephrectomy at the time of transplant failure.
- •Is receiving an immediate release tacrolimus maintenance immunotherapy regimen at the time of allograft failure.
排除标准
- •Has another functioning organ transplanted (eg. pancreas, liver, cardiac) at the time of kidney allograft failure.
- •Allograft failure within a month of transplant.
- •Patients who are due to receive or receiving peritoneal dialysis following graft failure.
- •Patients with detectable DSA at the time of allograft failure
- •Receiving an extended release preparation of tacrolimus as immunotherapy at the time of graft failure.
- •Requires continuation of maintenance immunosuppression other than prednisolone or tacrolimus (eg. Mycophenolate mofetil or sirolimus).
- •Patients who on IR-FK conversion would require less than 0.75mg of Envarsus.
- •HLA type of donor is unknown.
- •Has a history of, or active co-morbidity that in the Investigator's opinion, could affect the conduct of the study.
- •Has any condition at the time of recruitment which would prohibit or pose a relative contraindication for the continued use of tacrolimus to a target trough level of between 3-5ng/ml
- •Active bacterial, viral (including CMV and EBV) or parasitic infections, including tuberculosis that, in the Investigator's opinion, could affect the conduct of the study.
- •Has active malignancy.
- •Female patients of child bearing age, who wish to consider pregnancy.
研究组 & 干预措施
Extended release tacrolimus
Active Comparator
干预措施: Envarsus Oral Product (Drug)
结局指标
主要结局
Incidence of de novo allosensitisation (donor specific antibodies) at 24 months post allograft failure.
时间窗: 24 months
Number of patients who develop new DSA in each group
次要结局
- Coefficient of variation of tacrolimus levels at 24 months post allograft failure.(24 months)
- Medication adherence measurement(24 months)
- Adverse events(24 months)
- Health-Related Quality of Life measurement(24 months)
- Chances of re-transplantation as determined by the transplant matchability calculator available from NHSBT(24 months)
- Proportion of patients retransplanted during the study period(24 months)
研究者
研究点 (1)
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