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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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pilot study

Conditions

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Renal Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Sirolimus

Intervention Type DRUG

Non interventional. Sirolimus administered by Principal Investigator per standard practice and labeling.

Interventions

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Sirolimus

Non interventional. Sirolimus administered by Principal Investigator per standard practice and labeling.

Intervention Type DRUG

Other Intervention Names

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Rapamune

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No