Immune Status in Solid Organ Transplantation

Organ Transplants Clinical Trial

Official title:

Evaluation of Predictors of Immune Status in Solid Organ Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070901
• Other study ID #: PROG-9F09
• Status: Completed
• Phase: N/A
• First received: February 17, 2010
• Last updated: February 4, 2013
• Start date: May 2010
• Est. completion date: March 2012

Study information

• Verified date: February 2013
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Organ Transplants

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune Markers		0, 3, 6, 9, 12 months	No