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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00044720
First Posted: September 6, 2002
Last Update Posted: August 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00044720     History of Changes
Other Study ID Numbers: 0468H1-101164
First Submitted: September 4, 2002
First Posted: September 6, 2002
Last Update Posted: August 18, 2009
Last Verified: August 2009

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
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs