Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen
Phase 4
Completed
- Conditions
- Renal Transplantation
- Registration Number
- NCT00170820
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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 / exclusion criteria may apply
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Renal function at M6 (glomerular filtration and tubular function).
- Secondary Outcome Measures
Name Time Method Mucous and cutaneous disorders 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) Incidence of biopsy-proven acute rejections and CMV infections Monitoring of everolimus trough levels. Adverse events and serious adverse events, premature study treatment discontinuations.
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland
Novartis🇨🇭Basel, Switzerland