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
• 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

• Kidney Transplantation
• Liver Transplantation

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