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

Pfizer

Status: Completed

Conditions: Renal Transplantation

Treatments: Drug: Sirolimus

Study type: Observational

Funder types: Industry

Identifiers

NCT00697112

B1741025

0468H-102385

Details and patient eligibility

About

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.

Full description

pilot study

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

53 participants in 1 patient group

A

Treatment:

Drug: Sirolimus