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

This study has been completed.
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00839709
First received: February 5, 2009
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Liver Disease
Liver Transplantation
 Procedure: blood sampling

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Peripheral Immunologic Response of Solid Organ Transplant Recipients to Depletion vs. Non-depletion Protocols

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Biospecimen Retention:   Samples With DNA

blood


Estimated Enrollment: 30
Study Start Date: March 2009
Study Completion Date: February 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
depletion immunosuppression Procedure: blood sampling
peripheral blood draw
no depletion immunosuppression Procedure: blood sampling
peripheral blood draw

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

liver transplant recipients

Criteria

Inclusion Criteria:

  • liver transplant recipient

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839709

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Jorge D Reyes, MD University of Washington
  More Information

No publications provided

Responsible Party: Jorge Reyes, M.D., University of Washington
ClinicalTrials.gov Identifier: NCT00839709     History of Changes
Other Study ID Numbers: 34710-B
Study First Received: February 5, 2009
Last Updated: March 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
liver disease
liver transplantation
depletion immunosuppression
non-depletion immunosuppression

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013