Role of Donor Genetics and Recipient Genetics in Kidney Transplant Outcomes

NCT01143532 | Completed

• 2 other identifiers: 10013510-DK-0135
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Participants in kidney transplant where both donor and recipient were of black African descent.
• 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.

Conditions

Kidney Disease; Kidney Transplantation; Kidney Failure, Chronic

Keywords

African-Americans; MYH9; Chronic Allograft Nephropathy; Chronic Kidney Disease; Proteinuria; Natural History; Kidney Disease; Kidney Transplant; African-American

Outcome Measures

Primary Outcomes (1)

• Whether variation in other donor genes might contribute to donor and recipient outcomes

  Will identify 300 kidney transplant dyads (donor/recipient pairs), which both individuals were of African descent and the kidney transplants were performed between 1995-2006. We hypothesize that genetic variants in the kidney donor affect kidney donor outcomes. Kidney donors have an increased prevalence of microalbuminuria.

  1995-2006

Secondary Outcomes (1)

• Whether recipient genotype contributes to recipient outcomes.

  1995-2006

Study Arms (2)

Kidney transplant donor of black African descent.

Kidney transplant donor of black African descent.

Kidney transplant recipient of black African descent

Kidney transplant recipient of black African descent.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Will identify 300 kidney transplant dyads (donor/recipient pairs), which both individuals were of African descent and the kidney transplants were performed between 1995-2006. We hypothesize that genetic variants in the kidney donor affect kidney donor outcomes. Kidney donors have an increased prevalence of microalbuminuria.

You may qualify if:

• We will study 300 African American kidney transplant dyads.
• African descent donor and African descent recipient
• Kidney transplant performed Jan 1995 - Dec 2006.
• First kidney transplant
• Kidney only transplant (excluding transplant of any other organ at any other time).

You may not qualify if:

• 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.
• We will exclude recipients who had HIV, hepatitis B or hepatitis C infection diagnosed either before or after the kidney transplant.
• Children
• Pregnant women will be excluded but invited to participate after delivery. The rationale is the renal function is altered during pregnancy

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Proteinuria

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Study Officials

• Jeffrey B Kopp, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 14, 2010
• Study Start: August 12, 2010
• Primary Completion: October 19, 2015
• Study Completion: October 19, 2015
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

US (1)