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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
History of Changes
  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:

U.S. FDA Resources

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
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:
Graft vs Host Disease
Kidney Failure, Chronic
Renal Insufficiency
Immune System Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 17, 2013