Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study.
- Conditions
- rejection kidney transplant100474381002765610038430
- Registration Number
- NL-OMON46987
- Lead Sponsor
- nefrologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>This pilot study is an exploratory, randomized-controlled trial. The primary<br /><br>endpoint of this study is a number of immunological measurements and not<br /><br>clinical efficacy nor safety. These immunological measurments are:<br /><br>I. Number of cytokine-producing alloreactive CD137+ T-cells<br /><br>II. Total number of infectious episodes<br /><br>III. Vaccination response score.<br /><br><br /><br>The feasibility outcomes will be:<br /><br>- estimation of the risk on BPAR in the control group<br /><br>- recruitment rates.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameters will be:<br /><br>- BPAR rate 15 months after kidney transplantation<br /><br>- presence of complement-fixating alloantibodies.<br /><br>- renal allograft function (eGFR with CKD-EPI formula and proteinuria expressed<br /><br>in urine protein/creatinine ratio).<br /><br>- number of donor-specific CD137+ T cells<br /><br>- composition of leucocyte subsets<br /><br>- blood pressure levels and number of antihypertensive drugs after<br /><br>discontinuation of MMF versus controls<br /><br>- gastrointestinal side effects and quality of life outcomes</p><br>