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NCT00839709 Clinical Trial

Peripheral Immunologic Response of Solid Organ Transplant Recipients to Depletion Versus Non-depletion Protocols

Liver Transplantation Clinical Trial

Official title:
Peripheral Immunologic Response of Solid Organ Transplant Recipients to Depletion vs. Non-depletion Protocols

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00839709
Other study ID # 34710-B
Secondary ID
Status Completed
Phase N/A
First received February 5, 2009
Last updated March 1, 2011
Start date March 2009
Est. completion date February 2011

Study information
Verified date March 2011
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Rejection and infection are primary causes of morbidity and mortality in solid organ transplant recipients. Current clinical practice relies on immunosuppressive drug levels measured in plasma to reflect the peripheral immune response in solid organ transplant recipients. Direct measurement of the number and functions of the immune cells themselves using multi-parameter flow cytometry may enable individualized immunosuppression management for organ transplant recipients. Multi-parameter flow cytometry will be used to compare levels and functional capabilities of multiple lymphocyte subsets between cohorts of patients receiving depletion induction and those receiving a non-depletion regimen. The activation state, cytotoxic potential and the functional capabilities of these cells will be examined within patients over the first six months post transplant.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date February 2011
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- liver transplant recipient

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• blood sampling
peripheral blood draw

Locations
Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

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