Genomics of Kidney Transplantation

Completed

Conditions studied: KidneyTransplant Recipients, Simultaneous Kidney/Pancreas Recipients, Kidney Transplant Donor

In brief

The major aim of this research study is to investigate the relationship between genetic variation in DNA (inherited code material in the cells of the body) and factors affecting transplant outcomes, like the drugs people receive or the way their immune systems work, for example. To do this, investigators will collect blood samples from participants. Genetic material will be separated from each blood sample and analyzed, looking for genetic variation.

Key facts

Study ID

NCT01714440

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

1552

Starts

2012-08-01

Expected to finish

2017-01-01

Last updated by the study team

2017-06-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Kidney (or kidney-pancreas) transplant recipient no more than 10 days post-transplant or kidney donor no more than 30 days post-transplant or previously enrolled in Phase I of the Genomics of Kidney Transplantation Study;
• No organs other than kidney or pancreas transplanted simultaneously with the qualifying kidney transplant; and
• Participant or parent/guardian must be able to understand and provide written informed consent.
• Inclusion for the Activity and mRNA Expression Cohort:
• Recipient enrolled in the Main Cohort Study;
• Informed consent for participation in the Activity and mRNA Expression Cohort;
• Age 18 years or greater as of day of transplantation;and
• Will receive tacrolimus, cyclosporine or mycophenolate as part of maintenance immunosuppression therapy.

You may not qualify if…

• Inability or unwillingness of the participant or parent/guardian to give a written informed consent or comply with the study protocol.
• For the Activity and mRNA Expression Cohort:
• Inability or unwillingness of the participant or parent/guardian to give a written informed consent for participation in the Activity and mRNA Expression Cohort or comply with the study protocol.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Alberta — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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