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

Charité University Medicine Berlin

Status and phase

Completed

Phase 4

Conditions

Renal Transplantation

Treatments

Drug: everolimus

Drug: enteric-coated mycophenolate sodium

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00443937

CRAD001ADE05

Details and patient eligibility

About

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

Enrollment

15 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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