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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Kidney Failure; Atherosclerosis

Treatments: Drug: tacrolimus; Drug: prednisone; Drug: mycophenolate mofetil; Drug: sirolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00311311

0468H1-319

Details and patient eligibility

About

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.

Full 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 sites and have all end of study procedures performed by Dec 31, 2011.

The decision to terminate this study was made following the conduct of an interim analysis which demonstrated that the study did not reach its primary endpoint. The termination of this study was not driven by any safety concerns and had no impact on subject safety and well-being.

Enrollment: 72 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

1

Active Comparator group

Description:

Tacrolimus + MMF + Steroids

Treatment:

Drug: mycophenolate mofetil

Drug: tacrolimus

Drug: mycophenolate mofetil

Drug: prednisone

Drug: tacrolimus

Drug: prednisone

2

Experimental group

Description:

Tacrolimus + MMF + Steroids with conversion from Tacrolimus to Sirolimus at 3-4 months post-transplant

Treatment:

Drug: mycophenolate mofetil

Drug: tacrolimus

Drug: sirolimus

Drug: mycophenolate mofetil

Drug: prednisone

Drug: tacrolimus

Drug: prednisone