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Immune Status in Solid Organ Transplantation
This study has been completed.
Sponsor:
Dartmouth-Hitchcock Medical Center
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
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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 ]
| 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) |
| 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
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
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 |
ClinicalTrials.gov processed this record on July 21, 2017