NCT00332839

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

Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a CNI-free Regimen With Enteric-coated Mycophenolate Sodium and Everolimus in Comparison to Standard Therapy With Enteric-coated Mycophenolate Sodium and Ciclosporin Microemulsion in Stable Renal Transplant Patients

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Everolimus	Participants, switching from the CsA based treatment, initially received everolimus 1.5 mg/day and then from day 7, 3 mg/day, and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml). Participants, switching from the tacrolimus based treatment, initially received 3 mg/day and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml).
DRUG	Cyclosporin A (CsA)	The dose was based on the participants' blood level of C0h (80-150 ng/ml).
DRUG	Tacrolimus	The dose was based on the participants' blood level of C0h (5-10 ng/ml).
DRUG	Enteric Coated - Mycophenolate Sodium (EC-MPS)	The dose was ≥ 720 mg/day.
DRUG	Corticosteroids	Corticosteroids were given according to local standard and/or the Investigators' discretion.

Timeline

• Start date: 2005-11-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2006-06-02
• Last updated: 2014-08-28
• Results posted: 2014-08-28

Locations

11 sites across 1 country: Germany