NCT00839709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 3, 2011

Status Verified

March 1, 2011

Enrollment Period

1.5 years

First QC Date

February 5, 2009

Last Update Submit

March 1, 2011

Conditions

Liver DiseaseLiver Transplantation

Keywords

liver diseaseliver transplantationdepletion immunosuppressionnon-depletion immunosuppression

Study Arms (2)

depletion immunosuppression

Procedure: blood sampling

no depletion immunosuppression

Procedure: blood sampling

Interventions

blood samplingPROCEDURE

peripheral blood draw

depletion immunosuppressionno depletion immunosuppression

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

liver transplant recipients

You may qualify if:

  • liver transplant recipient

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Liver Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jorge D Reyes, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 9, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2010

Study Completion

February 1, 2011

Last Updated

March 3, 2011

Record last verified: 2011-03

Locations

US(1)