NCT00044720

Brief Summary

The incidence of efficacy failure at 12 months between two regimens.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
484

participants targeted

Target at P75+ 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

First Submitted

Initial submission to the registry

September 4, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

August 18, 2009

Status Verified

August 1, 2009

First QC Date

September 4, 2002

Last Update Submit

August 17, 2009

Conditions

Chronic Kidney FailureGraft vs Host DiseaseKidney Transplantation

Keywords

Kidney Transplant

Interventions

RapamuneDRUG

Eligibility Criteria

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

You may qualify if:

  • Age: 13 years or older, 40 kgs or more
  • End-stage renal disease
  • African-American/Black transplant recipient and/or repeat renal transplant recipient who lost a previous allograft

You may not qualify if:

  • Evidence of active infection
  • Evidence abnormal chest x-ray
  • Patients with HIV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, ChronicGraft vs Host Disease

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 4, 2002

First Posted

September 6, 2002

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

August 18, 2009

Record last verified: 2009-08