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

Tracking Information
First Received Date ^ICMJE	February 17, 2010
Last Updated Date	February 4, 2013
Start Date ^ICMJE	May 2010
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 4, 2013)	Immune Markers [ Time Frame: 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01070901 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Immune Status in Solid Organ Transplantation
Official Title ^ICMJE	Evaluation of Predictors of Immune Status in Solid Organ Transplantation
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Tranplant clinic population
Condition ^ICMJE	Organ Transplants
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Organ transplant recipients
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	March 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01070901
Other Study ID Numbers ^ICMJE	PROG-9F09
Has Data Monitoring Committee	No
Responsible Party	Dartmouth-Hitchcock Medical Center
Study Sponsor ^ICMJE	Dartmouth-Hitchcock Medical Center
Collaborators ^ICMJE	Astellas Pharma Inc
Investigators ^ICMJE	Not Provided
Information Provided By	Dartmouth-Hitchcock Medical Center
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top