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Immune Status in Solid Organ Transplantation

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01070901
First received: February 17, 2010
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose
Immunosuppressive therapy protocols in solid organ transplantation are rudimentary, differ by transplant center and no practical strategies are available to guide an individuals' response to immune suppression. In this study we will conduct research to assess immunologic status in solid organ transplant recipients, predicting immune reconstitution and outcomes after transplant to better guide the use of immunosuppressive medications.

Condition
Organ Transplants

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Predictors of Immune Status in Solid Organ Transplantation

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Immune Markers [ Time Frame: 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
Enrollment: 20
Study Start Date: May 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Organ transplant recipients

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tranplant clinic population
Criteria

Inclusion Criteria:

  • Impending kidney transplant
  • Age >18
  • Able to provide informed consent and comply with the study procedures

Exclusion Criteria:

  • Age<18
  • Concomitant illness, which by decision of investigator, may compromise the ability to perform this trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070901

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Astellas Pharma Inc
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01070901     History of Changes
Other Study ID Numbers: PROG-9F09 
Study First Received: February 17, 2010
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 30, 2016