EUCTR2018-000652-18-GB进行中（未招募）1 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 - EVITRA Study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Able to give informed consent.
- •2.Male or female, at least 18 years of age.
- •3.Has renal allograft failure and is due to start haemodialysis therapy, or within 28 days following starting dialysis.
- •4.Has been already activated on the transplant wait list or is undergoing work up to be reactivated on the transplant live.
- •5.Has no indication at the time of transplant failure for graft nephrectomy.
- •6.Is receiving an immediate release tacrolimus maintenance immunotherapy regimen at the time of allograft failure.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1.Has another functioning organ transplanted (eg. pancreas, liver, cardiac) at the time of kidney allograft failure.
- •2. Allograft failure within a month of transplantation.
- •3.Patients who are due to receive or receiving peritoneal dialysis following graft failure.
- •4.Patients with detectable DSA at the time of allograft failure
- •5.Receiving an extended release preparation of tacrolimus as immunotherapy at the time of graft failure.
- •6.Requires continuation of maintenance immunosuppression other than prednisolone or tacrolimus (eg. Mycophenolate mofetil or sirolimus).
- •7.Patients who on IR-FK conversion would require less than 0.75mg of Envarsus.
- •8. HLA type of donor unknown.
- •9.Has a history of, or active co-morbidity that in the Investigator’s opinion, could affect the conduct of the study.
- •10.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
- •11.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.
- •12.Has active malignancy.
- •13.Female patients of child bearing age, who wish to consider pregnancy.
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