NCT00443937

Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Renal Transplant Patients

Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Stable Renal Transplant Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Cyclosporine (CNI), a potent immunosuppressive drug used in transplant recipients to prevent graft rejection, can cause renal impairment in some patients. The aims of this study are * To determine the influence of CNI discontinuation on the drug exposure and key pharmacokinetic parameters of everolimus and enteric-coated mycophenolate sodium (EC-MPS) * To determine the adequate dosing of everolimus and EC-MPS in a CNI-free regimen * To investigate the CNI-free regimen with EC-MPS and everolimus with respect to safety (e.g. rejection rates) and tolerability * To investigate renal function after CsA withdrawal

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	enteric-coated mycophenolate sodium	oral
DRUG	everolimus	oral

Timeline

• Start date: 2004-01-01
• Completion: 2006-03-01
• First posted: 2007-03-07
• Last updated: 2007-11-02

Locations

1 site across 1 country: Germany