IMPROVEMENT OF RENAL FUNCTION BY CONVERSION OF TACROLIMUS TO EVEROLIMUS 3 MONTHS AFTER KIDNEY TRANSPLANTATIO
- Conditions
- Kidney Transplantation
- Registration Number
- EUCTR2010-019398-14-NL
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Adult patients (18 years or older) who have received an ABO-compatible single-organ kidney transplant from a living donor and who participated in study METC-2010-080 will be eligible for entry into the study.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patients need to be on immunosuppressive therapy with tacrolimus and mycophenolate mofetil at 3 months after transplantation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): For this conversion study renal function is the primary endpoint. Mean MDRD clearances will be compared between tacrolimus and everolimus treated patients at month 12. Also changes in MDRD clearances within individual patients in the tacrolimus and everolimus treated patients between month 3 and 12 will be compared. ;Secondary Objective: Apart from renal function also changes in renal histology <br>following conversion of tacrolimus-based immunosuppression to everolimus-<br>based immunosuppression will be studied.<br>;Main Objective: The aim of this study is to investigate if conversion of tacrolimus-based <br>immunosuppression to everolimus-based immunosuppression results in <br>preservation of renal function as compared to continued tacrolimus-based <br>immunosuppression.
- Secondary Outcome Measures
Name Time Method