NCT00420537

Shift to Everolimus (RAD) Kidney Sparing Study

Safety and Efficacy of Low-dose Cyclosporine in Association With Everolimus to Minimize Renal Dysfunction in Heart Transplant Recipients

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Dysfunction
• Heart Transplantation

Interventions

Type	Name	Description
DRUG	cyclosporine	cyclosporine trough levels between 100 and 150
DRUG	cyclosporine	cyclosporine trough levels between 40 and 90 ng/ml
DRUG	Mycophenolate mofetil	mycophenolate with low doses
DRUG	Everolimus

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-01-01
• Completion: 2009-03-01
• First posted: 2007-01-11
• Last updated: 2010-01-12

Locations

1 site across 1 country: Italy