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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Medical University of Vienna.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00461357
First received: April 17, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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 4

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

Resource links provided by NLM:

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

ClinicalTrials.gov Identifier: NCT00461357     History of Changes
Other Study ID Numbers: NTX-OFO-01
Study First Received: April 17, 2007
Last Updated: April 17, 2007
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

ClinicalTrials.gov processed this record on May 16, 2013