Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.

Summary

Calcineurin inhibitors (CNI), a potent immunosuppressive drug used in kidney transplant recipients to prevent graft rejection, may cause renal impairment. The aim of this study is to assess whether a CNI-free regimen with enteric-coated mycophenolate sodium and everolimus is as safe and well tolerated as a standard regimen consisting of enteric-coated mycophenolate sodium and cyclosporine microemulsion without a compromise in therapeutic efficacy while resulting in an improved renal function.

Timeline

Start

2005-11

Primary completion

2013-03

Completion

2013-03

Outcome

Outcome not reported

Stopped (Enrollment): “The trial was terminated early due to slow enrollment. It was determined that the planned sample size of 300 could not be achieved.”

Drugs

Indications

No indication recorded.