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Immune Status in Solid Organ Transplantation

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ClinicalTrials.gov Identifier: NCT01070901
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : February 5, 2013
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
Organ Transplants

Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Predictors of Immune Status in Solid Organ Transplantation
Study Start Date : May 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Organ transplant recipients


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Immune Markers [ Time Frame: 0, 3, 6, 9, 12 months ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01070901     History of Changes
Other Study ID Numbers: PROG-9F09
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013