Study Stopped
PI leaving institution
Cytokine Kinetics Test to Assess the Presence or Absence of Tolerance in Organ Transplant
Cytokine Kinetics Assay to Assess the Presence or Absence of Tolerance in Organ Transplant Recipients
1 other identifier
observational
15
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedMay 12, 2016
May 1, 2016
1.8 years
December 26, 2007
May 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation between cytokine kinetics test and clinical status of subject
1 year
Study Arms (3)
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 Criteria
Kidney or liver transplant recipients
You may qualify if:
- Kidney or liver transplant recipients for whom donor cells are available
You may not qualify if:
- HcT \<32%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin
Madison, Wisconsin, 53792, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 3, 2008
Study Start
September 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
May 12, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share