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

Completed

• Conditions: Liver Disease; Liver Transplantation
• Interventions: Procedure: blood sampling

• Registration Number: NCT00839709
• Lead Sponsor: University of Washington

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-05
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Study Start: 2009-03
• Primary Completion: 2010-09
• Study Completion: 2011-02
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-01
• Last Update Posted: 2011-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• liver transplant recipient

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
depletion immunosuppression	blood sampling	-
no depletion immunosuppression	blood sampling	-

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States