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

Renal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443937
• Other study ID #: CRAD001ADE05
• Status: Completed
• Phase: Phase 4
• First received: March 6, 2007
• Last updated: October 31, 2007
• Start date: January 2004
• Est. completion date: March 2006

Study information

• Verified date: October 2007
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• enteric-coated mycophenolate sodium
oral
• everolimus
oral

Locations

Country	Name	City	State
Germany	Charité-Universitätsmedizin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinetic Profiles (MPA, everolimus, and optional IMPDH) will be measured at day 0, 7 and 7 days after complete removal of CsA and last dose adjustment of everolimus due to trough level outside target range		7 days
Primary	Everolimus trough level will be measured at day 7, 14, 21, 28 and month 2, 4, 6, 9, 12		1 year
Secondary	Safety and tolerability of the treatment regimen consisting over a one year period		1 year
Secondary	Renal function during the course of the trial, especially after CNI withdrawal.		1 year
Secondary	Routine laboratory parameters during the course of the trial.		1 year