Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study. - Tacrolimus monotherapy.

Erasmus Medical Center0 个研究点开始时间: 2014年7月8日最近更新: 2017年10月2日

研究概览

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•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•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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