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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Renal Transplantation

Keywords

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Kidney Transplantation Renal Transplantation Mycophenolate Cyclosporine Everolimus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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enteric-coated mycophenolate sodium

oral

Intervention Type DRUG

everolimus

oral

Intervention Type DRUG

Other Intervention Names

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Myfortic Certican

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Klemens Budde, Prof.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité-Universitätsmedizin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CRAD001ADE05

Identifier Type: -

Identifier Source: org_study_id