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Study Evaluating Rapamune in Patients After Kidney Transplantation

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00240214
Collaborator
(none)
500
Enrollment
1
Location
82
Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
An Open Label Post Marketing Surveillance Assessment to Evaluate the Effectiveness and Safety of Rapamune in Patients After Kidney Transplantation Receiving a Rapamune Containing Regime
Study Start Date :
Apr 1, 2001
Actual Primary Completion Date :
Feb 1, 2008
Actual Study Completion Date :
Feb 1, 2008

Arms and Interventions

Arm Intervention/Treatment
1

sirolimus

Drug: sirolimus
Tablet, dosage is determined by trough level

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients having received a renal allograft from a cadaveric or living donor with low or moderate risk of developing acute rejection episodes.
    Exclusion Criteria:
    • Contraindications according to Summary of the Product Characteristics (SmPC).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Multiple Cities Germany

    Sponsors and Collaborators

    • Wyeth is now a wholly owned subsidiary of Pfizer

    Investigators

    • Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
    • Principal Investigator: Trial Manager, For Germany, medinfoDEU@wyeth.com

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00240214
    Other Study ID Numbers:
    • 0468E-100875
    First Posted:
    Oct 17, 2005
    Last Update Posted:
    Mar 14, 2008
    Last Verified:
    Mar 1, 2008
    Keywords provided by , ,
    Kidney transplants
    Additional relevant MeSH terms:
    Sirolimus

    Study Results

    No Results Posted as of Mar 14, 2008