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Can a gene found in african ancestry explain kidney failure?

NCT ID NCT04160507

Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study creates a biorepository of blood and urine samples from adults of African ancestry, including those with end-stage kidney disease and healthy controls. The goal is to support research on APOL1 gene mutations, which are linked to kidney disease and are only found in people with recent African ancestry. By collecting and storing these samples, researchers aim to enable future studies on biomarkers and epigenetics that could improve understanding and treatment of kidney failure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
No drug or treatment is given. This study collects blood and urine samples for research.
What this could lead to
If successful, this biorepository could provide the samples needed to develop better ways to detect, treat, or prevent kidney failure in people of African ancestry.
What could go wrong
This is a sample collection study, not a treatment trial, so it will not directly change patient care. The value depends on future research using the stored samples.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic kidney disease end stage renal failure kidney disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

End-stage kidney disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27705, United States

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