DANB: Duke ApoL1 Nephropathy Biorepository
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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 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.
|
Outcome Measures
Primary Outcome Measures
- Biorepository [5 years]
Number of biological samples collected and stored (whole blood and urine).
Secondary Outcome Measures
- Future study samples [5 years]
1) Number of biological samples for future studies, including epigenetic and biomarker research.
Other Outcome Measures
- Understanding the mechanisms by which mutations in ApoL1 gene cause kidney disease, including identification of cellular and epigenetic risk factors [5 years]
Number of biological samples to understand the mutations in ApoL1
Eligibility Criteria
Criteria
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.
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Healthy black adults, age 50 and older with no known history of kidney disease will be recruited as controls
Exclusion Criteria:
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Black adult cases with diabetic nephropathy
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Healthy controls with kidney disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University Medical Center | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- Duke University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00103657