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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. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Medical University of Vienna.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461357
First Posted: April 18, 2007
Last Update Posted: April 18, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
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)
  Contacts and Locations
Information from the National Library of Medicine

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
  More Information

ClinicalTrials.gov Identifier: NCT00461357     History of Changes
Other Study ID Numbers: NTX-OFO-01
First Submitted: April 17, 2007
First Posted: April 18, 2007
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