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

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ClinicalTrials.gov Identifier: NCT00461357
Recruitment Status : Unknown
Verified April 2007 by Medical University of Vienna.
Recruitment status was:  Active, not recruiting
First Posted : April 18, 2007
Last Update Posted : April 18, 2007
Sponsor:
Information provided by:
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.


Condition or disease
Kidney Function After Transplantation Outcome After Kidney Transplantation

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

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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)

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461357


Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Ferdinand Muehlbacher, MD Professor Medical University of Vienna; Department of Transplantation

ClinicalTrials.gov Identifier: NCT00461357     History of Changes
Other Study ID Numbers: NTX-OFO-01
First Posted: April 18, 2007    Key Record Dates
Last Update Posted: April 18, 2007
Last Verified: April 2007

Keywords provided by Medical University of Vienna:
Old for Old
Eurotransplant Senior Program
Glomerular Filtration Rate