Shift to Everolimus (RAD) Kidney Sparing Study
Phase 4
Terminated
- Conditions
- Kidney DysfunctionHeart Transplantation
- Interventions
- Registration Number
- NCT00420537
- Lead Sponsor
- University of Bologna
- Brief Summary
The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- Heart Transplant with 1 to 4 years of follow-up
- GFR between 20 and 60 ml/min (calculated with Colkoroft-Gault formula)
Exclusion Criteria
- Acute rejection in the previous 6 months
- Contraindications to statin therapy
- Ongoing infection
- Ongoing heart failure
- Myocardial infarction or myocardial revascularization after transplant
- Malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Everolimus Everolimus Everolimus with cyclosporine trough levels between 40 and 90 ng/ml mycophenolate cyclosporine Mycophenolate mofetil with cyclosporine trough levels between 100 and 150 Everolimus cyclosporine Everolimus with cyclosporine trough levels between 40 and 90 ng/ml mycophenolate Mycophenolate mofetil Mycophenolate mofetil with cyclosporine trough levels between 100 and 150
- Primary Outcome Measures
Name Time Method Calculated GFR One year after randomization
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Policlinico S.Orsola-Malpighi
🇮🇹Bologna, Italy