Duke APOL1 Research Biorepository

NCT04160507 | Recruiting

• 1 other identifier: Pro00103657
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

ESKD; APOL 1 gene; Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Biorepository

  Number of biological samples collected and stored (whole blood and urine).

  5 years

Secondary Outcomes (1)

• Future study samples

  5 years

Other Outcomes (1)

• Understanding the mechanisms by which mutations in ApoL1 gene cause kidney disease, including identification of cellular and epigenetic risk factors

  5 years

Study Arms (2)

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.

Other: Biorepository

black adult cases with non-diabetic nephropathy

black adult cases with non-diabetic nephropathy

Other: Biorepository

Interventions

Biorepository OTHER

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.

Healthy black adults 50 and over; black adult cases with non-diabetic nephropathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mutation in ApoL1 gene is associated with increased risk of non-diabetic kidney disease in individuals of recent African descent-i.e., only black people are affected. Therefore, black adult cases with non-diabetic nephropathy or healthy controls aged 18 years or older will be recruited for consent into the DANB. 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 at various stages of kidney disease and those without any clinical evidence of kidney disease.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononuclear cells (PBMCs) will be isolated from the blood using standard Ficoll-Paque technique. A fraction of the PBMCs will be cryopreserved and stored at for future analysis. We will submit a separate IRB protocol for use of future unspecified research with these samples. The remaining fraction of PBMCs will be used to generate inducible pluripotentent stem cells (iPSCs). These iPSC would be differentiated into kidney cells which could then be further studied. While no plans exist to immortalize any of these cell lines, the consent form does allow for creating immortalized cell lines in the future. Residual plasma will also be stored separately for additional analysis. Kidney cells shed into urine would also be a potential source of iPSCs.

MeSH Terms

Conditions

Kidney Failure, Chronic; Kidney Diseases

Interventions

Biological Specimen Banks

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Central Study Contacts

Opeyemi Olabisi, MD/PHD

CONTACT

919-660-6987; opeyemi.olabisi@duke.edu

Maurice W Smith, MA

CONTACT

9196131386; maurice.w.smith@duke.edu

Study Design

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

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: December 13, 2019
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)