Immediate Conversion From Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients

• Status: Withdrawn
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients.

Interest in developing CNI-free regimens using other agents such as the proliferation signal inhibitor everolimus.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Calcineurin Inhibitors; Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion criteria

• Primary or secondary renal transplantation in the past 12-36 months.

• Current immunosuppressive therapy consisting of Tacrolimus together with MMF +/-corticosteroids.

• Moderately impaired renal function

Exclusion criteria

• Multi-organ recipients or previous transplantation with an organ other than a kidney.

• Acute rejection episodes in the last 6 months.

Other protocol-defined inclusion/exclusion criteria may apply.