NCT04160507 · Duke University
Duke APOL1 Research Biorepository
(DARB)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Biorepository
Time frame: 5 years
Number of biological samples collected and stored (whole blood and urine).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 18, 2025 · Source of record for eligibility and locations