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Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00044720
Collaborator
(none)
484
Enrollment

Study Details

Study Description

Brief Summary

The incidence of efficacy failure at 12 months between two regimens.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
484 participants
Allocation:
Randomized
Masking:
None (Open Label)
Official Title:
An Open-label, Concentration Controlled, Randomized, 12 Month Study of Prograf + Rapamune + Cor
Actual Primary Completion Date :
Jul 1, 2005
Actual Study Completion Date :
Jul 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    • Age: 13 years or older, 40 kgs or more

    • End-stage renal disease

    • African-American/Black transplant recipient and/or repeat renal transplant recipient who lost a previous allograft

    Exclusion Criteria

    • Evidence of active infection

    • Evidence abnormal chest x-ray

    • Patients with HIV.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Wyeth is now a wholly owned subsidiary of Pfizer

    Investigators

    • Study Director: Medical Monitor, MD, Wyeth is now a wholly owned subsidiary of Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00044720
    Other Study ID Numbers:
    • 0468H1-101164
    First Posted:
    Sep 6, 2002
    Last Update Posted:
    Aug 18, 2009
    Last Verified:
    Aug 1, 2009
    Keywords provided by , ,
    Kidney Transplant
    Additional relevant MeSH terms:
    Renal Insufficiency
    Kidney Failure, Chronic
    Graft vs Host Disease
    Sirolimus

    Study Results

    No Results Posted as of Aug 18, 2009