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
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

No publications provided 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
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
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