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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00443937
First Posted: March 7, 2007
Last Update Posted: November 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by:
Charite University, Berlin, Germany
  Purpose

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

Condition Intervention Phase
Renal Transplantation Drug: enteric-coated mycophenolate sodium Drug: everolimus Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Stable Renal Transplant Patients

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 [ Time Frame: 7 days ]
  • Everolimus trough level will be measured at day 7, 14, 21, 28 and month 2, 4, 6, 9, 12 [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Safety and tolerability of the treatment regimen consisting over a one year period [ Time Frame: 1 year ]
  • Renal function during the course of the trial, especially after CNI withdrawal. [ Time Frame: 1 year ]
  • Routine laboratory parameters during the course of the trial. [ Time Frame: 1 year ]

Estimated Enrollment: 15
Study Start Date: January 2004
Study Completion Date: March 2006
Intervention Details:
    Drug: enteric-coated mycophenolate sodium
    oral
    Other Name: Myfortic
    Drug: everolimus
    oral
    Other Name: Certican
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443937


Locations
Germany
Charité-Universitätsmedizin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Novartis
Investigators
Principal Investigator: Klemens Budde, Prof. Charite University, Berlin, Germany
  More Information

ClinicalTrials.gov Identifier: NCT00443937     History of Changes
Other Study ID Numbers: CRAD001ADE05
First Submitted: March 6, 2007
First Posted: March 7, 2007
Last Update Posted: November 2, 2007
Last Verified: October 2007

Keywords provided by Charite University, Berlin, Germany:
Kidney Transplantation
Renal Transplantation
Mycophenolate
Cyclosporine
Everolimus

Additional relevant MeSH terms:
Everolimus
Sirolimus
Mycophenolic Acid
Cyclosporins
Cyclosporine
Mycophenolate mofetil
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors


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