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Completed

NCT Number: NCT00443937

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

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

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Key information

Conditions

Renal Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charité-Universitätsmedizin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteric-Coated Mycophenolate Sodium

Drug

oral

Other names: Myfortic

Everolimus

Drug

oral

Other names: Certican

Primary outcomes

  1. 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

  2. Everolimus trough level will be measured at day 7, 14, 21, 28 and month 2, 4, 6, 9, 12

    Time frame: 1 year

Secondary outcomes

  1. Safety and tolerability of the treatment regimen consisting over a one year period

    Time frame: 1 year

  2. Renal function during the course of the trial, especially after CNI withdrawal.

    Time frame: 1 year

  3. Routine laboratory parameters during the course of the trial.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Mar 7, 2007
Registry last updated
Nov 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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