NCT00470665

Brief Summary

The purpose of this study is to assess whether in high-risk kidney transplant patients (patients whose previous kidney transplant failed, have a high PRA lab test result or are of African-American descent) that a combination of Rapamune with Prograf and steroids will prevent acute rejection as well as Rapamune and cyclosporine and steroids.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2007

Completed
Last Updated

May 8, 2007

Status Verified

May 1, 2007

First QC Date

May 7, 2007

Last Update Submit

May 7, 2007

Conditions

Renal Allograft Recipients

Outcome Measures

Primary Outcomes (1)

  • First biopsy-confirmed acute rejection, patient death or graft loss in the first 12 months following transplantation. First occurence of kidney graft loss or patient death in the first 12 months following transplantation.

Interventions

RapamuneDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of African-American descent or patient with a history of multiple transplants and/or patients with a high panel reactive antibody lab test with a renal transplant from a cadaveric donor, a living unrelated donor or a living-related mismatched donor.
  • Age \>= 13 years, weight \>= 40 kg
  • Women must have a negative pregnancy test at study entry

You may not qualify if:

  • Multiple organ transplants or double kidney transplants (pediatric en-bloc or double adult)
  • Active systemic infection, or localized major infection or known HIV
  • Patients with residual kidney function \>20 mL/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Oliveras L, Lopez-Vargas P, Melilli E, Codina S, Royuela A, Coloma Lopez A, Fava A, Manonelles A, Couceiro C, Lloberas N, Cruzado JM, Montero N. Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function. Cochrane Database Syst Rev. 2025 Apr 8;4(4):CD014855. doi: 10.1002/14651858.CD014855.pub2.

    PMID: 40197799DERIVED

  • Gaber AO, Kahan BD, Van Buren C, Schulman SL, Scarola J, Neylan JF; Sirolimus High-Risk Study Group. Comparison of sirolimus plus tacrolimus versus sirolimus plus cyclosporine in high-risk renal allograft recipients: results from an open-label, randomized trial. Transplantation. 2008 Nov 15;86(9):1187-95. doi: 10.1097/TP.0b013e318187bab0.

    PMID: 19005398DERIVED

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 7, 2007

First Posted

May 8, 2007

Study Start

August 1, 2002

Study Completion

July 1, 2004

Last Updated

May 8, 2007

Record last verified: 2007-05