NCT01070901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

1.8 years

First QC Date

February 17, 2010

Last Update Submit

February 4, 2013

Conditions

Organ Transplants

Outcome Measures

Primary Outcomes (1)

  • Immune Markers

    0, 3, 6, 9, 12 months

Study Arms (1)

Organ transplant recipients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tranplant clinic population

You may qualify if:

  • Impending kidney transplant
  • Age \>18
  • Able to provide informed consent and comply with the study procedures

You may not qualify if:

  • Age\<18
  • Concomitant illness, which by decision of investigator, may compromise the ability to perform this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 18, 2010

Study Start

May 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

US(1)