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

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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 affect the progression of atherosclerosis in renal transplant recipients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

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 Criteria:

• 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.