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

April 17, 2007 updated by: Medical University of Vienna

Outcome After Renal Transplantation of a Randomized Prospective Trial in the Eurotransplant Senior Program

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment

48

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Ferdinand Muehlbacher, MD Professor, Medical University of Vienna; Department of Transplantation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Anticipated)

December 1, 2007

Study Registration Dates

First Submitted

April 17, 2007

First Submitted That Met QC Criteria

April 17, 2007

First Posted (Estimate)

April 18, 2007

Study Record Updates

Last Update Posted (Estimate)

April 18, 2007

Last Update Submitted That Met QC Criteria

April 17, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NTX-OFO-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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