Sirolimus Based Immunosuppression for Patients Undergoing Kidney Transplantation in the Eurotransplant Senior Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2007-12-31

Brief Summary

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The Eurotransplant Senior Program (ESP) started in 1999 with local allocation of kidneys from deceased donors elder than 65 years to recipients elder than 65 years. The requirements for immunosuppression in this group of patients are high due to the large amount of comorbidities.

This prospective randomized trial compared the standard immunosuppressive protocol based on cyclosporine A (CyA) used at our center within the ESP, to a calcineurin inhibitor-free protocol based on sirolimus (SRL).

The aim of this study is to investigate the effect of a CNI-free therapy on the function of elderly kidneys 6 months post transplantation, measured by GFR.

Detailed Description

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Conditions

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Kidney Function After Transplantation Outcome After Kidney Transplantation

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Recipients of the Eurotransplant Senior Program
* negative cytotoxic crossmatch
* signed informed consent

Exclusion Criteria

* High sensitized recipients (PRA \> 40%)
* Non heart Beating Donor
* Hyperlipidemia
* Leucocytopenia (\< 3000/mm3)
* Thrombocytopenia (\< 75000/mm3)

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ferdinand Muehlbacher, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna; Department of Transplantation

Other Identifiers

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NTX-OFO-01

Identifier Type: -

Identifier Source: org_study_id