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

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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

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

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborator: Novartis
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus

Criteria

Inclusion Criteria:

• Patients having a kidney transplant since at least 6 months but for no longer than 5 years.

• Patients in a stable condition in terms of graft function

• Patients currently receiving EC-MPS and CsA with or without corticosteroids as part of their immunosuppressive regimen for at least 1 month prior to Baseline

• Females of childbearing potential must have a negative serum pregnancy test prior to study inclusion. If positive, the patient will not be enrolled. Effective contraception must be used during the trial.

Exclusion Criteria:

• Patients with any known hypersensitivity to EC-MPS or everolimus or other components of the formulation (e.g., lactose)

• Patients with a history of severe rejection (according to BANFF criteria) within 3 months of enrollment in this trial.

• Changes to the immunosuppressive regimen during the last 3 months due to immunologic reasons.

• Patients with thrombocytopenia (platelets <100,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (leukocytes <4,500/mm3), and/or hemoglobin <9.0 g/dL at baseline.

• Patients with proteinuria at baseline (> 1g/d)

Other protocol-defined inclusion/exclusion criteria may apply