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

February 17, 2010
February 4, 2013
May 2010
March 2012   (final data collection date for primary outcome measure)
Immune Markers [ Time Frame: 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01070901 on ClinicalTrials.gov Archive Site
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Immune Status in Solid Organ Transplantation
Evaluation of Predictors of Immune Status in Solid Organ Transplantation

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Tranplant clinic population

Organ Transplants
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Organ transplant recipients
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01070901
PROG-9F09
No
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Astellas Pharma Inc
Not Provided
Dartmouth-Hitchcock Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP