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Cytokine Kinetics Test to Assess the Presence or Absence of Tolerance in Organ Transplant

This study has been terminated.
(PI leaving institution)
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585858
First received: December 26, 2007
Last updated: June 5, 2008
Last verified: June 2008
History of Changes
  Purpose

The purpose of this pilot study is to determine if there is clinical correlation between the CKT and transplant recipients who are known to be on minimal or no immunosuppression (presumed tolerant) and those who are on conventional amounts of immunosuppression and have either experienced rejection (presumed hyper-responsive to donor) or have not experienced rejection (unknown responsive state).


Condition
Kidney Transplantation
Liver Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cytokine Kinetics Test to Assess the Presence or Absence of Tolerance in Organ Transplant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Correlation between cytokine kinetics test and clinical status of subject [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subjects on mimimal or no immunosuppression and no rejection history
2
Subjects who have had rejection on conventional immunosuppression
3
Subjects who have not had acute or chronic rejection who are on conventional immunosuppression

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Kidney or liver transplant recipients

Criteria

Inclusion Criteria:

  • Kidney or liver transplant recipients for whom donor cells are available

Exclusion Criteria:

  • HcT <32%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585858

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Stuart Knechtle, MD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00585858     History of Changes
Other Study ID Numbers: 2006-0437, 2006-0437
Study First Received: December 26, 2007
Last Updated: June 5, 2008
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013