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

NCT ID: NCT00839709

Last Updated: 2011-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-02-28

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.

Conditions

Liver Disease; Liver Transplantation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

depletion immunosuppression

blood sampling

Intervention Type: PROCEDURE

peripheral blood draw

no depletion immunosuppression

blood sampling

Intervention Type: PROCEDURE

peripheral blood draw

Interventions

blood sampling

peripheral blood draw

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• liver transplant recipient

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

University of Washington

Principal Investigators

Jorge D Reyes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

34710-B

Identifier Type: -

Identifier Source: org_study_id