Safe Renal Function In Long Term Heart Transplanted Patients (SAREFU)

A.O. Ospedale Papa Giovanni XXIII

Status and phase: Unknown; Phase 4

Conditions: Kidney Diseases; Heart Transplantation

Treatments: Drug: Everolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00505102

SAREFU123

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 1 patient group

A

Active Comparator group

Treatment:

Drug: Everolimus