Ignite Creation Date:
2024-05-06 @ 1:55 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04160507
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2019-11-08
Brief Title:
Duke APOL1 Research Biorepository
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Duke APOL1 Research Biorepository
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DARB
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 ie 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
The mutations in ApoL1 gene that are strongly associated with kidney disease are only present in individuals of recent African ancestry ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None