Sirolimus Based Immunosuppression for Patients Undergoing Kidney Transplantation in the Eurotransplant Senior Program - Full Text View

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

This study is ongoing, but not recruiting participants.

First Received: April 17, 2007 No Changes Posted

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00461357

Purpose

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.

Condition	Phase
Kidney Function After Transplantation Outcome After Kidney Transplantation	Phase IV

Study Type:	Observational
Study Design:	Longitudinal, Random Sample, Prospective Study
Official Title:	Outcome After Renal Transplantation of a Randomized Prospective Trial in the Eurotransplant Senior Program

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Estimated Enrollment:	48
Study Start Date:	January 2003
Estimated Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461357

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Ferdinand Muehlbacher, MD Professor

Medical University of Vienna; Department of Transplantation

More Information

No publications provided

Study ID Numbers:	NTX-OFO-01
Study First Received:	April 17, 2007
Last Updated:	April 17, 2007
ClinicalTrials.gov Identifier:	NCT00461357 History of Changes
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:

Old for Old
Eurotransplant Senior Program
Glomerular Filtration Rate

Study placed in the following topic categories:

Sirolimus

ClinicalTrials.gov processed this record on September 04, 2009