Safe Renal Function In Long Term Heart Transplanted Patients
- Registration Number
- NCT00505102
- Lead Sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Brief Summary
The purpose of this study is to verify whether the reduction of cyclosporine dosages associated with Everolimus administration may improve renal function as compared to patients maintained on standard immunosuppressive therapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Heart Transplant patients with more than 1 year of follow-up
- Creatinine lower than 3.5 mg/dl
- GFR Higher than 20 ml/min (calculated with Cockcroft-Gault formula)
- Cyclosporine in maintenance immunosuppressive therapy
- Patient must be able to sign an approve informed consent
- Prior History of acute rejection within the last 3 months
- Females of childbearing age may be included if pregnancy is excluded and acceptable contraception measures are used
Exclusion Criteria
- Patients who are recipients of multiple organ transplants
- Prior or current use of sirolimus or everolimus
- History of acute rejection within the last 6 months
- Coronary Artery Bypass Surgery or other cardiac surgery in the past 3 months
- Patient not able to attend all follow-up evaluations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Everolimus -
- Primary Outcome Measures
Name Time Method Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin 2 years
- Secondary Outcome Measures
Name Time Method All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace 2 years
Trial Locations
- Locations (2)
Heart Transplantad Center OspedaliRiuniti Bergamo
🇮🇹Bergamo, Italy
Heart Transplant Center Ospedali Riuniti
🇮🇹Bergamo, Italy