Heart Transplantation, Kidney Diseases
Conditions
Keywords
Kidney Diseases, Heart Transplantation, Everolimus, Cyclosporine Toxicity
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
Interventions
DRUGEverolimus
cyclosporine dose reduced of 50% after introduction of everolimus
Sponsors
Mario Negri Institute for Pharmacological Research
A.O. Ospedale Papa Giovanni XXIII
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace | 2 years |
Countries
Italy
Outcome results
None listed