Status:
TERMINATED
Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients
Lead Sponsor:
Pfizer
Conditions:
Atherosclerosis
Kidney Failure
Eligibility:
All Genders
35+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affe...
Detailed Description
A decision to terminate the study was taken in November 2011 and a communication to that effect sent to all participating sites on November 18. All sites were asked to have patients returned to the si...
Eligibility Criteria
Inclusion
- At least one of the following characteristics:
- History of dialysis for at least 3 years.
- History of diabetes for at least 5 years.
- Hypertension or ischemic nephropathy as a cause of the end stage renal disease or loss of the first transplant.
- History of coronary artery disease, stroke, myocardial infarction, or amputation for vascular disease.
Exclusion
- History of malignancy within the last 5 years (except adequately treated skin cancer).
- Recipients of non-renal organ transplant.
- Active gastrointestinal disease that may interfere with drug absorption.
- Active HIV, hepatitis B or C infection.
- Women who are pregnant or breastfeeding.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00311311
Start Date
April 1 2006
End Date
January 1 2012
Last Update
September 23 2013
Active Locations (8)
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1
Pfizer Investigational Site
Rochester, New York, United States, 14642
2
Pfizer Investigational Site
Calgary, Alberta, Canada, T2N 2T9
3
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 2B7
4
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8N 4A6