Genomics of Kidney Transplantation



Status:Terminated
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:Any
Updated:2/10/2017
Start Date:August 2012
End Date:January 2017

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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.

In the past, the major problems in kidney transplantation were surgical complications, acute
rejection, and infections. Right now, researchers are focusing on improving immune
suppression therapy and achieving better long-term survival of kidney transplants. One of
the ways to try to understand what causes loss of function after many years is to find out
if there is a genetic factor involved.

There are a number of differences in specific genes that have been identified and are
thought to affect transplant outcomes. Studying these gene variations (differences between
people or differences between populations) is important in determining whether these
variations are related to transplant outcomes and how this information can help patients
achieve better long-term transplant survival.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
5
sites
Rochester, Minnesota 55905
Principal Investigator: F. G. Cosio, MD
Phone: 507-538-8764
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Arthur Matas, MD
Phone: 612-625-1172
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Birmingham, Alabama 35294
Principal Investigator: R. Mannon, MD
Phone: 205-996-2577
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Birmingham, AL
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Edmonton, Alberta T6G 2J2
Principal Investigator: Sita Gourishankar, MD
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Minneapolis, Minnesota 55414
Principal Investigator: Bertram Kasiske, MD
Phone: 612-347-5871
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Minneapolis, MN
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