Renal Transplantation
Conditions
Keywords
Renal transplantation, maintenance, switch, everolimus, CNI-free
Brief summary
The purpose of this study is to assess if a combination of everolimus, steroids, and mycophenolate mofetil is associated with a better renal function than sirolimus.
Interventions
DRUGEverolimus
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Inclusion criteria
* First or second renal transplantation (1 to 10 years post-transplant) * Treatment with sirolimus + mycophenolate mofetil + steroids + ACE inhibitor or angiotensin II receptor antagonist + statin
Exclusion criteria
* Treatment with a CNI or azathioprine * Vascular rejection or biopsy-proven acute rejection within 3 months prior to screening * Severe dyslipidemia Other protocol-defined inclusion /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal function at M6 (glomerular filtration and tubular function). | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of biopsy-proven acute rejections and CMV infections | — |
| Laboratory parameters: hemoglobin, WBC, T-cell sub-populations, platelets, transaminases, total cholesterol, HDL and LDL cholesterol, apolipoproteins A1 and B, triglycerides, fasting glucose, HbA1c, LH, FSH, testosterone and TSH | — |
| Renal function (other tubular function parameters) | — |
| Adverse events and serious adverse events, premature study treatment discontinuations. | — |
| Monitoring of everolimus trough levels. | — |
| Mucous and cutaneous disorders | — |
Countries
Switzerland
Outcome results
None listed