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Protocol Details

Role of Donor Genetics and Recipient Genetics in Kidney Transplant Outcomes

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-DK-0135

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: 99

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

African-Americans;
MYH9;
Chronic Allograft Nephropathy;
Chronic Kidney Disease;
Proteinuria

Recruitment Keyword(s)

Kidney Disease;
Kidney Transplant;
African-American

Condition(s)

Kidney Disease;
Kidney Transplantation;
Kidney Failure, Chronic

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Background:

- Genetic variation in a particular chromosome is a major contributor to the increased risk for kidney disease that is common in people of African descent, although the specific gene, mutations, and other aspects of the variations remain to be determined. By studying the outcomes of kidney transplant in donors and recipients of African descent, researchers hope to better understand the effects of this genetic variation on the success of kidney transplants.

Objectives:

- To examine possible connections between genetic variations and kidney transplant outcomes for donors and recipients.

Eligibility:

-<TAB>Participants in kidney transplant where both donor and recipient were of black African descent.

-<TAB>Eligible transplants include both living donor and deceased donor.

Design:

- The study will involve one visit of up to 8 hours.

- All participants will provide a detailed personal and family medical history.

- All participants will provide blood and urine samples, including a 24-hour urine collection, to test kidney function and collect material for genetic testing.

- Donor participants will also have a magnetic resonance imaging (MRI) scan of their remaining kidney.

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Eligibility

INCLUSION CRITERIA:

We will study 300 African American kidney transplant dyads.

INCLUSION CRITERIA FOR DYADS:

1. African descent donor and African descent recipient

2. Kidney transplant performed Jan 1995 - Dec 2006.

3. First kidney transplant

4. Kidney only transplant (excluding transplant of any other organ at any other time).

EXCLUSION CRITERIA:

1. We will exclude donors whose kidneys were used in transplants in which two organs were transplanted, e.g. pancreas and kidney, either simultaneously or at separate times. We will exclude donors whose kidneys were used in second or subsequent transplants. Rationale: dual organ transplants and serial transplants are more complicated clinical situations and renal allograft survival may be shorter and thus not comparable with other kidney transplants.

2. We will exclude recipients who had HIV, hepatitis B or hepatitis C infection diagnosed either before or after the kidney transplant.

3. Children

4. Pregnant women will be excluded but invited to participate after delivery. The rationale is the renal function is altered during pregnancy


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Jeffrey B. Kopp, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 3N114
10 CENTER DR
BETHESDA MD 20814
(301) 594-3403
jeffreyk@mail.nih.gov

Jeffrey B. Kopp, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 3N114
10 CENTER DR
BETHESDA MD 20814
(301) 594-3403
jeffreyk@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01143532

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