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

• Conditions: Kidney Function After Transplantation; Outcome After Kidney Transplantation

• Registration Number: NCT00461357
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Not available

Study Timeline

• Study Start: 2003-01
• Status Verified: 2007-04
• Study First Submitted: 2007-04-17
• Study First Submitted QC: 2007-04-17
• Last Update Submitted: 2007-04-17
• Study First Posted: 2007-04-18
• Last Update Posted: 2007-04-18
• Study Completion: 2007-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified