Study of APOL1 Genetic Testing to Understand Kidney Disease Risk and Patient Attitudes in African American Adults
Led by St. Louis University · Updated on 2025-03-20
600
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the role of specific genetic variants in the APOL1 gene that increase the risk of kidney failure in Black Americans. This study focuses on understanding the frequency of these APOL1 renal risk variants and how knowledge of ones genetic status affects attitudes towards managing hypertension and kidney health. The study also explores environmental and genetic interactions that may influence kidney disease progression in this population.
Participants will have one blood sample collected to determine their APOL1 genotype and will complete surveys about their beliefs and attitudes towards kidney disease, hypertension, diabetes, and genetic testing. Results are shared by phone, and follow-up surveys are conducted at 3 and 12 months to assess any changes in attitudes. Those found to have high-risk genotypes may speak with a genetic counselor if they wish.
During the study, participants complete initial and follow-up surveys and provide genetic samples. Researchers measure the frequency of APOL1 risk variants among participants and their first-degree relatives. The study monitors participant responses over one year to understand how genetic information impacts health management. Participation ranges from initial enrollment through a year of follow-up assessments.
CONDITIONS
Brief Title
APOL1 Genetic Testing in African Americans
Research Team
K
Krista Lentine, PhD, MD
M
Mary Lesko, RN
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Self-identify as Black, African American, or of African ancestry, including multi-racial individuals with African ancestry
You will not qualify if you...
Unable to provide informed consent due to cognitive impairment
Terminally ill
Currently receiving renal replacement therapy such as hemodialysis or peritoneal dialysis
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Assessment and Genetic Testing
Duration - Day of enrollment
Participants provide a blood sample for APOL1 genetic testing and complete an initial survey about their attitudes toward kidney disease, hypertension, diabetes, and genetic testing. Results are shared by phone shortly after testing.
1 visit (in-person)
Follow-up Surveys
Duration - 12 months
Participants complete follow-up surveys at 3 months and 12 months to assess any changes in attitudes and beliefs since learning their APOL1 genetic test results. Genetic counseling is offered to those with high-risk genotypes who are interested.
2 follow-up surveys (remote or in-person)
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
The Diagnostic Yield of Genomic Sequencing-based Genetic Kidney Disease Testing in Kidney Transplant Candidates: Experience at an Urban US Transplant Center.
Fadee Abu Al Rub, Rengin Elsurer Afsar, Vidya A Fleetwood...
Association of APOL1 variants with mild kidney disease in the first-degree relatives of African American patients with non-diabetic end-stage renal disease.
Barry I Freedman, Carl D Langefeld, Jolyn Turner...