Status:
COMPLETED
Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Renal Transplant Patients
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Novartis
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00443937
Start Date
January 1 2004
End Date
March 1 2006
Last Update
November 2 2007
Active Locations (1)
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1
Charité-Universitätsmedizin
Berlin, Germany, 10117