NCT00518375

Brief Summary

This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months were evaluated also.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 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

April 1, 2000

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2007

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 20, 2007

Completed
Last Updated

December 11, 2023

Status Verified

August 1, 2007

First QC Date

July 27, 2007

Last Update Submit

December 7, 2023

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Calculated creatinine clearance to evaluate renal function at 12 months post transplantation

    12 months

Secondary Outcomes (1)

  • Incidence of acute graft rejection at 6 and 12 months post transplantation and patient and graft survival at 12 months post transplantation

    12 months

Interventions

Rapamune® (Sirolimus)DRUG
Neoral® (Cyclosporine)DRUG
CorticosteroidsDRUG

Left up to local practice but steroids are typically used perioperatively

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults more than 18 years of age
  • End-stage renal disease, with 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 their primary graft for at least 6 months

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

SirolimusCyclosporineAdrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

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 20, 2007

Study Start

April 1, 2000

Study Completion

May 1, 2001

Last Updated

December 11, 2023

Record last verified: 2007-08