Sirolimus Based Immunosuppression for Patients Undergoing Kidney Transplantation in the Eurotransplant Senior Program
This trial is active, not recruiting.
|Conditions||kidney function after transplantation, outcome after kidney transplantation|
|Sponsor||Medical University of Vienna|
|Start date||January 2003|
|End date||December 2007|
|Trial size||48 participants|
|Trial identifier||NCT00461357, NTX-OFO-01|
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.
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)
|Official title||Outcome After Renal Transplantation of a Randomized Prospective Trial in the Eurotransplant Senior Program|
|Principal investigator||Ferdinand Muehlbacher, MD Professor|
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