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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:
ClinicalTrials.gov Identifier:
NCT00585858
First Posted: January 3, 2008
Last Update Posted: May 12, 2016
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 (Responsible Party):
University of Wisconsin, Madison
  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 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 ]

Enrollment: 15
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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): NCT00585858


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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585858     History of Changes
Other Study ID Numbers: H-2006-0437
First Submitted: December 26, 2007
First Posted: January 3, 2008
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No