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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00839709
First Posted: February 9, 2009
Last Update Posted: March 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Washington
  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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
liver transplant recipients
Criteria

Inclusion Criteria:

  • liver transplant recipient

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jorge Reyes, M.D., University of Washington
ClinicalTrials.gov Identifier: NCT00839709     History of Changes
Other Study ID Numbers: 34710-B
First Submitted: February 5, 2009
First Posted: February 9, 2009
Last Update Posted: March 3, 2011
Last Verified: March 2011

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

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases