Overview

This trial is active, not recruiting.

Conditions kidney diseases, heart transplantation
Treatment everolimus
Phase phase 4
Targets mTOR, FKBP-12
Sponsor A.O. Ospedale Papa Giovanni XXIII
Collaborator Mario Negri Institute for Pharmacological Research
Start date January 2007
End date July 2009
Trial size 200 participants
Trial identifier NCT00505102, SAREFU123

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
everolimus
cyclosporine dose reduced of 50% after introduction of everolimus

Primary Outcomes

Measure
Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin
time frame: 2 years

Secondary Outcomes

Measure
All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Efficacy and Safety of Everolimus to SAve REnal Function (SAREFU) in Long Term Heart Transplanted Patients
Trial information was received from ClinicalTrials.gov and was last updated in February 2008.
Information provided to ClinicalTrials.gov by A.O. Ospedale Papa Giovanni XXIII.