Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients

Stopped early · Phase 3

Conditions studied: Atherosclerosis, Kidney Failure

In brief

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 affect the progression of atherosclerosis in renal transplant recipients.

Key facts

Study ID

NCT00311311

Run by

Pfizer

People needed

72

Starts

2006-04-01

Expected to finish

2012-01-01

Last updated by the study team

2013-09-23

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Rochester, New York, United States
• Pfizer Investigational Site — Calgary, Alberta, Canada
• Pfizer Investigational Site — Edmonton, Alberta, Canada
• Pfizer Investigational Site — Hamilton, Ontario, Canada
• Pfizer Investigational Site — London, Ontario, Canada
• Pfizer Investigational Site — Toronto, Ontario, Canada
• Pfizer Investigational Site — Toronto, Ontario, Canada
• Pfizer Investigational Site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.