Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients
August 17, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
An Open-label, Concentration Controlled, Randomized, 12 Month Study of Prograf + Rapamune + Cor
The incidence of efficacy failure at 12 months between two regimens.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
484
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Actual)
July 1, 2005
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
September 4, 2002
First Submitted That Met QC Criteria
September 5, 2002
First Posted (Estimate)
September 6, 2002
Study Record Updates
Last Update Posted (Estimate)
August 18, 2009
Last Update Submitted That Met QC Criteria
August 17, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency, Chronic
- Kidney Failure, Chronic
- Renal Insufficiency
- Graft vs Host Disease
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- 0468H1-101164
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.