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Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation

Sponsor
University Hospital Schleswig-Holstein (Other)
Overall Status
Completed
CT.gov ID
NCT00223028
Collaborator
(none)
15
Enrollment
3
Duration (Months)

Study Details

Study Description

Brief Summary

To investigate in renal transplant recipients the potential drug intreaction between Sirolimus, Mycophenolt Mofetil and Fluvastatin

All patient enrolled in this PKI-Study had no changes in the therapy before or because of the study. Only patients without changes more than 4 weeks before startin the study were included

Condition or Disease Intervention/Treatment Phase
  • Drug: sirolimus, mycophenolat mofetil, fluvastatin
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation
Study Start Date :
Apr 1, 2005
Study Completion Date :
Jul 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • renal transplant patients (18 - 65 years, inclusive)

    • cadaver and living renal transplants(1. Ntx, 2. Ntx)

    • Immunsuppression: sirolimus with or without Mycophenolat Mofetil und and fluvastatin Fluvastatin for a minimum of three months

    • writen informt consent by the patient

    Exclusion Criteria:

    • contraindications for statins

    • pregnancy or lactating

    • elevated liver or muscle encymes (> 2x up to normal values: AST, ALT, bilirubine, CPK)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital Schleswig-Holstein

    Investigators

    • Principal Investigator: Lutz Renders, MD, University of Schleswig-Holstein, Campus Kiel, Department of Nephrology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00223028
    Other Study ID Numbers:
    • 003
    First Posted:
    Sep 22, 2005
    Last Update Posted:
    Oct 28, 2005
    Last Verified:
    Jul 1, 2004
    Keywords provided by , ,
    fluvastain
    sirolimus
    mycophenolat mofetil
    renal transplantation
    Additional relevant MeSH terms:
    Sirolimus

    Study Results

    No Results Posted as of Oct 28, 2005