Duke APOL1 Research Biorepository (DARB)

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.

Study Overview

• Status: Recruiting
• Conditions: End Stage Kidney Disease
• Intervention / Treatment: Other: Biorepository

Detailed Description

The risk of end stage kidney failure among African Americans is 4 times that of Caucasian Americans. This excess risk of kidney failure is largely attributable to mutations in apolipoprotein L1 gene. While 10-15% of African Americans in the United States possess kidney disease-associated ApoL1 mutations, nearly 40% of African Americans on dialysis have these mutations. There are significant gaps in the understanding of the pathophysiology of ApoL1-nephropathy. Only some of the people with ApoL1 mutations develop kidney failure. The pathways that link ApoL1 mutations with end stage kidney failure are not understood. Because kidney biopsy is generally obtained from patients with evidence of kidney disease-whose kidneys have experienced significant damage and sclerosis-access to the relevant kidney cells is very limited. However, recent advancements in biomedical research have made it possible to develop kidney-like cells from inducible pluripotent stem cells (iPSCs) which were derived from blood cells of individuals. This innovative technique will allow us to generate iPSC-derived cells from the blood of individuals who have developed ApoL1-nephropathy for the purpose studying them in research lab so as to decipher the cellular mechanism of their kidney failure.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Opeyemi Olabisi, MD/PHD; Phone Number: 919-660-6987; Email: opeyemi.olabisi@duke.edu
• Study Contact Backup: Name: Maurice W Smith, MA; Phone Number: 9196131386; Email: maurice.w.smith@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University Medical Center
      • Principal Investigator: Opeyemi Olabisi, MD
      • Contact: Maurice W Smith, M.A.; Phone Number: 919-613-1386; Email: maurice.w.smith@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
black adult cases with non-diabetic nephropathy	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biorepository	Number of biological samples collected and stored (whole blood and urine).	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Future study samples	1) Number of biological samples for future studies, including epigenetic and biomarker research.	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Understanding the mechanisms by which mutations in ApoL1 gene cause kidney disease, including identification of cellular and epigenetic risk factors	Number of biological samples to understand the mutations in ApoL1	5 years

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Kidney Disease; ESKD; APOL 1 gene
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: Pro00103657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to share IPD data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No