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

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

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

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 identifier: NCT00044720

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information 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:
Graft vs Host Disease
Kidney Failure, Chronic
Renal Insufficiency
Immune System Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases processed this record on May 30, 2016