Shift to Everolimus (RAD) Kidney Sparing Study

University of Bologna

Status and phase: Terminated; Phase 4

Conditions: Heart Transplantation; Kidney Dysfunction

Treatments: Drug: Mycophenolate mofetil; Drug: cyclosporine; Drug: Everolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00420537

2006-003035-78

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

mycophenolate

Active Comparator group

Description:

Mycophenolate mofetil with cyclosporine trough levels between 100 and 150

Treatment:

Drug: cyclosporine

Drug: cyclosporine

Drug: Mycophenolate mofetil

Everolimus

Active Comparator group

Description:

Everolimus with cyclosporine trough levels between 40 and 90 ng/ml

Treatment:

Drug: cyclosporine

Drug: cyclosporine

Drug: Everolimus