Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
Phase 4
Completed
- Conditions
- Kidney Transplantation
- Registration Number
- NCT00170885
- Lead Sponsor
- Novartis
- Brief Summary
The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Recipients of deceased, living unrelated, or non-human leukocyte antigen (HLA) identical living related donor renal transplant who actually have a viable kidney transplant at the time of randomization (within 24 hours of graft reperfusion)
- The renal cold ischemic time must be < 36 hours.
- The age of the donor must be between 15 and 65 years.
Exclusion Criteria
- Patients who are recipients of multiple organ transplants, including more than one kidney
- Patients who have previously received an organ transplant which failed within one year
- Patients with current panel reactive T-cell antibody titers of 50% or more
- Patients who are recipients of A-B-O incompatible transplants or T-cell crossmatch positive transplant
Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment
- Secondary Outcome Measures
Name Time Method Count of CD4 and CD8 positive lymphocytes Metabolic control: lipids, glycaemic control, proteinuria, enzymes Ultrasound ejection fraction Major adverse cardiovascular events Pharmacokinetics (PK)
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland