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Genetic testing aims to tackle kidney disease racial gap

NCT ID NCT04191824

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving African American adults with high blood pressure early access to genetic testing for a kidney disease risk gene (APOL1) could improve their care. Over 6,700 participants were randomly assigned to get their genetic results right away or later. The goal was to see if early knowledge helped lower blood pressure and led to better monitoring of kidney health.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

6,789 people

The number who actually took part.

Started

Jul 2020

Finished

May 2024

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.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Self reported African ancestry * English Speaking * Age 18-70 years * Have diagnosis of hypertension: Diagnosis of hypertension is defined by either: * ICD10 diagnosis codes (i.e., I10; I11.x; I12.x; I13.x; I16.x) OR * On active antihypertensive therapy for indication of hypertension OR * Having systolic blood pressure of 140 mm Hg or greater in at least 2 of the last 3 consecutive recorded values in the EHR OR * Having hypertension in the patient's medical record problem list * Have been seen at ≥1 time in past year at a participating primary care site * Either: 1) do not have diabetes and do not have CKD, or 2) have CKD; Participants with diabetes may be included as long as they also have CKD. CKD is defined by either: A) ICD10 codes (i.e., N18.x; E08.22; E09.22; E10.22; E11.22;E13.22 (exclude Z94.0; N18.6; Z99.2)) OR B) Microalbumin/proteinuria level \>30 mg/g for 2 time periods ≥ 3 months. Values taken within 12 months of enrollment, unless 2 values are unavailable, then review within 24 months of enrollment. OR C) 15 ≤ eGFR ≤ 60 ml/min for 2 time periods ≥ 3 months. GFRs are taken within 12 months of enrollment, unless 2 values are unavailable, then review within 24 months. Diabetes is defined by: HbA1c ≥ 6.5 at least one time in the last year OR ICD10 diagnosis codes OR Having diabetes in the patient's medical record problem list. Exclusion Criteria: * Have diabetes, but no CKD. * Are currently on dialysis (ICD 10 codes N18.6, Z99.2 and Z94.0) * Have ESRD (eGFR\<15 ml/min) * Have a left ventricular assist device (LVAD) * Have a terminal illness * Have patient-reported known pregnancy at time of enrollment * Have had a liver, kidney, or allogeneic bone marrow transplant * Too cognitively impaired to provide informed consent and/or complete the study protocol * Institutionalized or too ill to participate (i.e. incarcerated, psychiatric or nursing home facility) * Plan to move out of the area within 6 months of enrollment * Not a current patient seeing a provider who cares for their hypertension (i.e., family medicine, internal medicine, nephrology, HIV provider, cardiology, hypertension specialists) at a participating site * Previously participated in the GUARDD pilot study OR have previously undergone APOL1 testing

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome hypertensive disorder kidney disorder

As listed by the trial registrant

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

Chronic kidney disease Hypertension

Contacts and locations

Locations

  • Baylor Research Institute

    Dallas, Texas, 75210, United States

  • Eskenazi Health

    Indianapolis, Indiana, 46202, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Meharry Medical College

    Nashville, Tennessee, 37208, United States

  • Nashville General Hospital

    Nashville, Tennessee, 37208, United States

  • Southeastern Healthcare

    Lumberton, North Carolina, 28358, United States

  • The Institute for Family Health

    New York, New York, 10035, United States

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Florida - Gainesville

    Gainesville, Florida, 32610, United States

  • University of Florida - Jacksonville

    Jacksonville, Florida, 32209, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15261, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.