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Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus

Primary Purpose

Kidney Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rapamune®
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Disease focused on measuring Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: = to ≥ 18 years. End-stage renal disease, with patients scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related donor. Patients with second and subsequent transplants must have maintained their primary graft for at least 6 months after transplantation (with the exception of graft failure due to technical reasons). Exclusion Criteria: Evidence of active systemic or localised major infection prior to initial Rapamune® administration. Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during screening. Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase. Exception: the use of erythropoiesis stimulating products. In these cases, erythrocyte-stimulating products must be discontinued prior to administration of Rapamune®.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Kidney Function at 12 months after transplantation.

    Secondary Outcome Measures

    Kidney function at 6 months; incidence of side effects and rejection at 6 and 12 months.

    Full Information

    First Posted
    November 2, 2005
    Last Updated
    March 9, 2010
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00248313
    Brief Title
    Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus
    Official Title
    A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporin Dose Reduction With Cyclosporin Elimination in de Novo Renal Allograft Recipients Receiving Rapamune
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    5. Study Description

    Brief Summary
    To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving induction therapy with cyclosporin (CsA, Neoral) and Rapamune® followed by CsA dose reduction and concentration-controlled Rapamune® versus induction with CsA and Rapamune® followed by discontinuation of CsA and concentration-controlled Rapamune®.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Disease
    Keywords
    Kidney Disease

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    470 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Rapamune®
    Primary Outcome Measure Information:
    Title
    Kidney Function at 12 months after transplantation.
    Secondary Outcome Measure Information:
    Title
    Kidney function at 6 months; incidence of side effects and rejection at 6 and 12 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: = to ≥ 18 years. End-stage renal disease, with patients scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related donor. Patients with second and subsequent transplants must have maintained their primary graft for at least 6 months after transplantation (with the exception of graft failure due to technical reasons). Exclusion Criteria: Evidence of active systemic or localised major infection prior to initial Rapamune® administration. Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during screening. Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase. Exception: the use of erythropoiesis stimulating products. In these cases, erythrocyte-stimulating products must be discontinued prior to administration of Rapamune®.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor, MD
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus

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