Kidney Transplantation
Conditions
Interventions
Trade Name: Certican
Product Name: Certican
Pharmaceutical Form: Capsule*
INN or Proposed INN: everolimus
CAS Number: 159351-69-6
Current Sponsor code: RAD-001
Other descriptive name: EVEROLIMUS
Conce
Sponsors
Erasmus Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Patients need to be on immunosuppressive therapy with tacrolimus and mycophenolate mofetil at 3 months after transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 following conversion of tacrolimus-based immunosuppression to everolimus- based immunosuppression will be studied. ;Main Objective: The aim of this study is to investigate if conversion of tacrolimus-based immunosuppression to everolimus-based immunosuppression results in preservation of renal function as compared to continued tacrolimus-based immunosuppression. | — |
Countries
Netherlands
Outcome results
None listed