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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00443937
First received: March 6, 2007
Last updated: October 31, 2007
Last verified: October 2007
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00443937     History of Changes
Other Study ID Numbers: CRAD001ADE05
Study First Received: March 6, 2007
Last Updated: October 31, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on April 17, 2014