Shift to Everolimus (RAD) Kidney Sparing Study

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bologna
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus

Criteria

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