Duke APOL1 Research Biorepository
ConditionEnd Stage Kidney Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Black adult cases with diabetic nephropathy
Healthy controls with kidney disease
Trial 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.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Biorepository
Other interventionTo 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Healthy black adults 50 and over1 intervention
Group B: black adult cases with non-diabetic nephropathy1 intervention
Trial outcomes
Primary outcomes
1
Biorepository
Number of biological samples collected and stored (whole blood and urine).
Time frame
5 yearsSecondary outcomes
1
Future study samples
1\) Number of biological samples for future studies, including epigenetic and biomarker research.
Time frame
5 yearsOther outcomes
1
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
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov