NCT00252655

Brief Summary

The purpose of this study is to evaluate the efficacy of Sirolimus (Rapamune) in improving the function of the transplant kidney, without any increase in the risk of acute rejection or adverse side effects, compared with Tacrolimus (Prograf). We hypothesize that Sirolimus, as one component of a long-term steroid-free immunosuppressive regimen, will be effective in maintaining a low incidence of acute rejection and a short- and long-term graft survival comparable to Tacrolimus with better graft function in the high-risk African-American renal transplant population with immediate graft function.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

April 19, 2007

Status Verified

April 1, 2007

First QC Date

November 9, 2005

Last Update Submit

April 18, 2007

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Renal function at 1, 3, 6, and 12 months post transplant.

Secondary Outcomes (1)

  • Incidence of acute rejection.

Interventions

Rapamune and PrografDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African-American living- or deceased-donor renal transplant at least 18 years of age with current and historical negative crossmatch who demonstrate urine output \> 60 ml/hr and fall in serum creatinine \> 20%/day during the first 48 hours posttransplant, without need for dialysis.

You may not qualify if:

  • Unwillingness to participate in the study
  • Current PRA \> 20%
  • Noncompliance with the protocol and follow-up visits
  • Those who need to be on maintenance steroids due to underlying disease
  • Known hypersensitivity to study drugs
  • Pregnancy
  • Pre-transplant leukopenia, thrombocytopenia, hypercholesterolemia, or hypertriglyceridemia despite optimal medical therapy
  • HIV positive recipients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Detroit Medical Center, Harper University Hospital

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Interventions

SirolimusTacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Scott A. Gruber, MD, PhD

    Harper University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 11, 2005

Study Start

January 1, 2004

Study Completion

June 1, 2009

Last Updated

April 19, 2007

Record last verified: 2007-04

Locations

US(1)