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

This study has been terminated.
(PI leaving institution)
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: December 26, 2007
Last updated: October 13, 2015
Last verified: October 2015
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).

Kidney Transplantation
Liver Transplantation

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

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)
Subjects on mimimal or no immunosuppression and no rejection history
Subjects who have had rejection on conventional immunosuppression
Subjects who have not had acute or chronic rejection who are on conventional immunosuppression


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Kidney or liver transplant recipients

Inclusion Criteria:

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

Exclusion Criteria:

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

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: University of Wisconsin, Madison Identifier: NCT00585858     History of Changes
Other Study ID Numbers: H-2006-0437
Study First Received: December 26, 2007
Last Updated: October 13, 2015
Health Authority: United States: Food and Drug Administration processed this record on November 27, 2015