Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this observational study is to examine the clinical outcomes of the use of sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD) under conditions of routine clinical practice. The primary objective is to identify the current criteria/reasons to use sirolimus as base therapy in this selected population and define and understand the emerging patterns of immunosuppressive treatment with sirolimus.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Patients aged 18 years or older.

• Patients who received a renal transplant (primary, secondary, tertiary, etc.) without pancreas, from Expanded Criteria Donors (ECD), 3 months prior and no later than 1 year at the time of study enrollment.

• Patients who provided informed consent.

• Patients without sirolimus as base therapy.

Exclusion Criteria:

• Patients who are unwilling or unable to provide informed consent or who lack a legal guardian or designee able to provide consent on their behalf.

• Patients who are unable to complete the study.

• Patients who are participating in another clinical trial during the last 6 months.

• Pregnant or lactating patients.