NCT00519116

Brief Summary

The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2000

Shorter than P25 for phase_4

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

October 1, 2000

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2007

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 21, 2007

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

First QC Date

July 27, 2007

Last Update Submit

December 7, 2023

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Calculated creatinine clearance at month 6 post transplantation

    6 months

Secondary Outcomes (1)

  • Patient and graft survival at 6 months post transplantation; the safety of sirolimus + corticosteroids given concomitantly with reduced or standard dose tacrolimus

    6 months

Interventions

Rapamune® (Sirolimus)DRUG
TacrolimusDRUG
Perioperative CorticosteroidsDRUG

The corticosteroids use was left up to the investigators decision.

Eligibility Criteria

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

You may qualify if:

  • At least 18 years of age
  • End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor
  • Patients with a secondary transplant must have maintained a primary graft for at least 6 months

You may not qualify if:

  • Planned antibody induction
  • Multiple organ transplants
  • History of malignancy within five years of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

SirolimusTacrolimus

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 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 27, 2007

First Posted

August 21, 2007

Study Start

October 1, 2000

Study Completion

August 1, 2001

Last Updated

December 11, 2023

Record last verified: 2023-12