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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014