NL-OMON46987已完成不适用
Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study. - Tacrolimus monotherapy.
nefrologie0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:;- Adult patients receiving a deceased or living kidney transplant in the Erasmus Medical Center Rotterdam, The Netherlands and:;- Historical PRA <5 and;- HLA MM <4.;Re-transplantation are allowed when meeting the before mentioned criteria.;Patients have to give written informed consent to participate in the study.;Before randomization at 6 months, renal function should be stable with eGFR (CKD-EPI formula) >30 in mL/min with proteinuria *0.5 gram per 10 mmol creatinin in spot urine.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:;- HLA identical living-related transplant recipients.;- Patients with an indication to continue MMF or other immunosuppressive drugs, e.g. vasculitis, SLE etc. (according to judgement of treating physician).;- Recipient of an ABO-incompatible allograft or with a positive crossmatch (complement-dependent cytotoxicity or flow cytometry).;- Biopsy proven rejection three months and later after transplantation.;- Recipient of multiple organ transplants.;- Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating or who are unwilling to use effective means of contraception.;- T-cell depleting therapy (anti-thymocyte globulin and alemtuzumab) after transplantation.
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