Chronic Kidney Disease
Conditions
Brief summary
Prospective, multicenter, randomized and open label study evaluating the benefit on renal function at 12 months post-transplantation, with an immunosuppression without calcineurin inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.
Interventions
DRUGEverolimus
Active Comparator
DRUGTacrolimus
Active Comparator
Experimental Arm
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients receiving a first kidney transplant from a cadaveric or living donor
Exclusion criteria
* Double transplant * Patient who has been treated with an immunosuppressive drug or study drug during the four weeks before administration of the first dose of Everolimus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal function as measured by estimated glomerular filtration rate GFR | One year after inclusion | GFR unit : mL / min / 1.73 m2 |
Countries
France
Outcome results
None listed