Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Sirolimus

About this trial

This is an interventional treatment trial for Graft Rejection focused on measuring Kidney Failure, Kidney Transplant

Eligibility Criteria

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

Inclusion Criteria: Age > 18 years. End-stage renal disease with subjects scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated mismatched donor, or from a living-related mismatched donor. Unreported HLA values will be considered a match. Women of childbearing potential must have a negative serum pregnancy test before administration of assigned treatment and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment. Other inclusions apply. Exclusion Criteria: Evidence of active systemic or localized major infection. Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, TAC or MMF. Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant). Other exclusions apply.

Sites / Locations

Outcomes

Primary Outcome Measures

Kidney function at 52 weeks after transplantation.

Secondary Outcome Measures

Kidney function at 26, 78 and 104 weeks after transplantation

Full Information

NCT ID

NCT00266123

First Posted

December 14, 2005

Last Updated

December 18, 2007

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00266123

Brief Title

Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients

Official Title

A Randomized Open-Label Study to Compare the Safety and Efficacy of Two Different Sirolimus Regimens With a Tacrolimus + Mycophenolate Mofetil Regimen in De Novo Renal Allograft Recipients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 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 demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at month 12 post-transplantation.

6. Conditions and Keywords

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

Graft Rejection, Kidney Failure, Kidney Transplant

Keywords

Kidney Failure, Kidney Transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

420 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Sirolimus

Primary Outcome Measure Information:

Title

Kidney function at 52 weeks after transplantation.

Secondary Outcome Measure Information:

Title

Kidney function at 26, 78 and 104 weeks after transplantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Age > 18 years. End-stage renal disease with subjects scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated mismatched donor, or from a living-related mismatched donor. Unreported HLA values will be considered a match. Women of childbearing potential must have a negative serum pregnancy test before administration of assigned treatment and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment. Other inclusions apply. Exclusion Criteria: Evidence of active systemic or localized major infection. Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, TAC or MMF. Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant). Other exclusions apply.

Overall Study Officials: