Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00044720
First received: September 4, 2002
Last updated: August 17, 2009
Last verified: August 2009
  Purpose

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


Condition Intervention Phase
Chronic Kidney Failure
Graft vs Host Disease
Kidney Transplantation
Drug: Rapamune
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Official Title: An Open-label, Concentration Controlled, Randomized, 12 Month Study of Prograf + Rapamune + Cor

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Enrollment: 484
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Evidence of active infection
  • Evidence abnormal chest x-ray
  • Patients with HIV.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044720

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00044720     History of Changes
Other Study ID Numbers: 0468H1-101164
Study First Received: September 4, 2002
Last Updated: August 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Kidney Transplant

Additional relevant MeSH terms:
Renal Insufficiency
Graft vs Host Disease
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Immune System Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 30, 2014