Recruiting

ApoL1 Nephropathy

Sponsor:

Duke University

Code:

NCT04160507

Conditions

End Stage Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Biorepository

Study Details

Brief summary:

The Duke ApoL1 Nephropathy Biorepository aims to address needs within non-diabetic kidney failure research by utilizing existing and, when necessary, developing new infrastructure to support the consent of patients and the collection of dedicated samples for ApoL1 Nephropathy biorepository.

The mutations in ApoL1 gene that are strongly associated with kidney disease are only present in individuals of recent African ancestry (i.e., black people). Caucasians do not have these ApoL1 mutations nor the associated kidney disease. Therefore, majority of subjects recruited for this study will be self-identified African Americans, Afro-Caribbean and other black individual. Study subjects will include individuals with end stage kidney disease and those without any clinical evidence of kidney disease.

Additionally, healthy black adults with no known history of kidney disease will be recruited as controls in this study because they are the only group that can fill this role.

Conditions

End Stage Kidney Disease

Study ID

NCT04160507

Start date

Dec 13, 2019

Status verified date

Dec, 2025

Completion date

Nov 15, 2026

Anticipated

Primary completion date

Nov 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Majority of subjects recruited for this study will be self-identified African Americans, Afro-Caribbean and other black individuals. Study subjects will include individuals at various stages of kidney disease and those without any clinical evidence of kidney disease.
  • Healthy black adults, age 50 and older with no known history of kidney disease will be recruited as controls

Exclusion Criteria:

  • Black adult cases with diabetic nephropathy
  • Healthy controls with kidney disease

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy black adults 50 and over

Healthy black adults age 50 and over with no known history of kidney disease will be recruited as controls in this study.

black adult cases with non-diabetic nephropathy

black adult cases with non-diabetic nephropathy

Interventions

Biorepository

To collect and store biological samples (whole blood and urine), along with relevant medical information, from adult inpatients and outpatients. Buffy coats will also be received from H3Africa Kidney Disease Research Network.

Primary outcome measure

  • Biorepository [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Principal Investigator:

Opeyemi Olabisi, MD

More Information

Sponsor

Duke University

Last update posted

Aug 27, 2026

Last verified

Dec, 2025

Keywords

  • ESKD
  • APOL 1 gene
  • Kidney Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-27.