Overview

This trial is active, not recruiting.

Conditions kidney function after transplantation, outcome after kidney transplantation
Phase phase 4
Sponsor Medical University of Vienna
Start date January 2003
End date December 2007
Trial size 48 participants
Trial identifier NCT00461357, NTX-OFO-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation random sample
Time perspective longitudinal

Eligibility Criteria

Male or female participants at least 65 years old.

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)

Additional Information

Official title Outcome After Renal Transplantation of a Randomized Prospective Trial in the Eurotransplant Senior Program
Principal investigator Ferdinand Muehlbacher, MD Professor
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by Medical University of Vienna.