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NCT00585858 Clinical Trial

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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00585858
Other study ID # H-2006-0437
Secondary ID
Status Terminated
Phase N/A
First received December 26, 2007
Last updated October 13, 2015
Start date September 2006
Est. completion date June 2008

Study information
Verified date October 2015
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Terminated
Enrollment 40
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- HcT <32%

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between cytokine kinetics test and clinical status of subject 1 year No
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