NCT00518271

Brief Summary

This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2000

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

April 1, 2000

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2007

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 20, 2007

Completed
Last Updated

August 20, 2007

Status Verified

August 1, 2007

First QC Date

July 26, 2007

Last Update Submit

August 16, 2007

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Graft function as measured by calculated creatinine clearance at month 6 post-transplantation.

Secondary Outcomes (1)

  • Blood serum creatinine, incidence of biopsy-confirmed acute graft rejection, and patient and graft survival at 6 months; presumptive acute rejection; incidence of infection; histologically-confirmed lymphoproliferative disease or malignancy.

Interventions

Rapamune® (Sirolimus)DRUG
TacrolimusDRUG
CorticosteroidsDRUG

Perioperative

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 donor
  • Patients with secondary kidney transplant must have maintained their primary graft for at least 6 months

You may not qualify if:

  • Planned antibody induction
  • Multiple organ transplants
  • Patients at high risk of acute rejection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

SirolimusTacrolimusAdrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 26, 2007

First Posted

August 20, 2007

Study Start

April 1, 2000

Study Completion

June 1, 2002

Last Updated

August 20, 2007

Record last verified: 2007-08