Expired Study
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Madison, Wisconsin 53792


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).


Criteria:

Inclusion Criteria: - Kidney or liver transplant recipients for whom donor cells are available Exclusion Criteria: - HcT <32%


Study is Available At:


Original ID:

H-2006-0437


NCT ID:

NCT00585858


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Wisconsin, Madison


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

PI leaving institution


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

15


Enrollment Type:

Actual


Study Dates

Start Date:September 2006
Completion Date:June 2008
Completion Type:Actual
Primary Completion Date:June 2008
Primary Completion Type:Actual
Verification Date:May 2016
Last Changed Date:May 10, 2016
First Received Date:December 26, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Correlation between cytokine kinetics test and clinical status of subject
Time Frame:1 year
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:3
Description:Subjects who have not had acute or chronic rejection who are on conventional immunosuppression
Study Arm Type:Other
Arm Name:2
Description:Subjects who have had rejection on conventional immunosuppression
Study Arm Type:Other
Arm Name:1
Description:Subjects on mimimal or no immunosuppression and no rejection history

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Wisconsin, Madison

Samples and Retentions

Study Population: Kidney or liver transplant recipients
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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