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New drug aims to plug leaky kidneys in APOL1 disease

NCT ID NCT06824987

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests an injectable drug called AZD2373 in 136 people with APOL1-mediated kidney disease, a genetic condition that mainly affects people of African descent. The goal is to see if the drug can reduce protein leakage into urine, a sign of kidney damage. Participants will receive either AZD2373 or a placebo for 30 weeks, and researchers will measure changes in urine protein levels.

What this could mean

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

Active substance
AZD2373 (an injectable drug)
What this could lead to
If it works, this could point toward a treatment that slows kidney damage in people with APOL1-related kidney disease, potentially delaying the need for dialysis or transplant.
What could go wrong
This is an early Phase 2b trial with only 136 participants, so results may not apply to everyone. The drug may not reduce protein in urine enough, or could have side effects not yet seen.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 136 people

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

Started

Mar 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 65 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: * Age: Male and female participants of African descent (including, but not limited to, Black, Black African, Black Caribbean, African American, Afro-Caribbean, Afro-Latino, West African, Mixed Black backgrounds, or other self-identified African diaspora heritage) aged 18 to 70 years, inclusive at the time of informed consent. * Participants who have high-risk APOL1 genotype (G1/G1; G1/G2; G2/G2). The screening period can be extended if there are delays related to the shipment, handling, or processing of genotype results. * A geometric mean UACR ≥ 300 mg/g calculated based on the mean of readings taken from 3 FMV urine samples collected on 3 consecutive days. Since the mean will be assessed for eligibility, any of the 3 readings may fall below 300 mg/g. * eGFR ≥ 25 mL/min/1.73m2. * Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Exclusion Criteria: * Participants with diagnosis of Type 1 diabetes mellitus. * Body Mass Index \> 45 kg/m2. * SBP \> 180 mmHg/DBP \> 110 mmHg (measured when the participant is considered to be at steady state, and preferably when they have taken their BP medications that same day). * QTcF \> 470 ms, except participants with bundle branch block who should excluded if QTcF\> 480 ms. * Acute coronary syndrome/Acute myocardial infraction with or without any coronary intervention within 6 months. * Transient ischaemic attack/ stroke within 3 months. * High grade (second to third) degree AV block or clinically significant sinus node dysfunction untreated with pacemaker. * A history of ventricular arrhythmias requiring treatment. * Participants with Type 2 diabetes mellitus must be excluded if ANY of the following conditions are present: 1. Current or past use of insulin for more than 3 months and/or any maintenance therapy with insulin within 2 months of screening. 2. Screening Haemoglobin A1c \> 8.0% 3. Receiving more than one anti-hyperglycaemic agent (excluding SGLT inhibitors and GLP-1 receptor agonists is permitted if prescribed for a purpose other than glycaemic control which can be taken in addition to one other anti-hyperglycaemic agent). * Participant on kidney replacement therapy (dialysis or kidney transplant) or any other organ transplant. * History or serologic evidence of autoimmune-mediated glomerular disease including but not limited to: lupus nephritis (positive lupus serology), ANCA associated vasculitis (antineutrophil cytoplasmic antibody), membranous nephropathy (anti-phospholipase A2 receptor antibody or other autoantibody associated with membranous nephropathy), anti-GBM disease (anti-GBM antibody), or IgA nephropathy. * Another underlying cause of kidney disease that is not associated with APOL1, including but not limited to polycystic kidney disease or, congenital anomalies of the kidney and urinary tract. * History of a diagnosed coagulopathy, a major unexplained bleeding event, or other high-risk bleeding diathesis. * A history of trypanosomiasis or leishmaniasis.

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Conditions

The condition(s) this trial relates to.

focal segmental glomerulosclerosis 4, susceptibility to

As listed by the trial registrant

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

APOL1-mediated 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

    88 sites in 2 countries. 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

  • Research Site

    RECRUITING

    Alabaster, Alabama, 35007, United States

  • Research Site

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    Birmingham, Alabama, 35205, United States

  • Research Site

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    Irondale, Alabama, 35210, United States

  • Research Site

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    Surprise, Arizona, 85374, United States

  • Research Site

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    Beverly Hills, California, 90211, United States

  • Research Site

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    Concord, California, 94520, United States

  • Research Site

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    Fremont, California, 94538, United States

  • Research Site

    RECRUITING

    Gardena, California, 90247, United States

  • Research Site

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • Research Site

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    Valencia, California, 91355, United States

  • Research Site

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    Boca Raton, Florida, 33487, United States

  • Research Site

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    Brandon, Florida, 33511, United States

  • Research Site

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    Miami, Florida, 33126, United States

  • Research Site

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    Miami, Florida, 33173, United States

  • Research Site

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    Orlando, Florida, 32808, United States

  • Research Site

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    Pompano Beach, Florida, 33060, United States

  • Research Site

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    Atlanta, Georgia, 30322, United States

  • Research Site

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    Augusta, Georgia, 30904, United States

  • Research Site

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    Augusta, Georgia, 30909, United States

  • Research Site

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    Augusta, Georgia, 30912, United States

  • Research Site

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    Columbus, Georgia, 31901, United States

  • Research Site

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    Columbus, Georgia, 31904, United States

  • Research Site

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    Duluth, Georgia, 30096, United States

  • Research Site

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    Hinesville, Georgia, 31313, United States

  • Research Site

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    Lawrenceville, Georgia, 30046, United States

  • Research Site

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    Macon, Georgia, 31210, United States

  • Research Site

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    Macon, Georgia, 31217, United States

  • Research Site

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    Marietta, Georgia, 30067, United States

  • Research Site

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    Savannah, Georgia, 31406, United States

  • Research Site

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    Stockbridge, Georgia, 30281, United States

  • Research Site

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    Chicago, Illinois, 60612, United States

  • Research Site

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    Hinsdale, Illinois, 60521, United States

  • Research Site

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    Rockford, Illinois, 61107, United States

  • Research Site

    RECRUITING

    Baton Rouge, Louisiana, 70808, United States

  • Research Site

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    Lafayette, Louisiana, 70508, United States

  • Research Site

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    New Orleans, Louisiana, 70112, United States

  • Research Site

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    Shreveport, Louisiana, 71103, United States

  • Research Site

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    Bethesda, Maryland, 20889, United States

  • Research Site

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    Potomac, Maryland, 20854, United States

  • Research Site

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    Boston, Massachusetts, 02114, United States

  • Research Site

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    Lansing, Michigan, 48911, United States

  • Research Site

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    Roseville, Michigan, 48066, United States

  • Research Site

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    Minneapolis, Minnesota, 55455, United States

  • Research Site

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    Tupelo, Mississippi, 38801, United States

  • Research Site

    RECRUITING

    Brooklyn, New York, 11203, United States

  • Research Site

    RECRUITING

    Brooklyn, New York, 11221, United States

  • Research Site

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    Laurelton, New York, 11413, United States

  • Research Site

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    New York, New York, 10010, United States

  • Research Site

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    Rockville Centre, New York, 11570, United States

  • Research Site

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    Cary, North Carolina, 27511, United States

  • Research Site

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    Durham, North Carolina, 27705, United States

  • Research Site

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    Fayetteville, North Carolina, 28304, United States

  • Research Site

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    Gastonia, North Carolina, 28054, United States

  • Research Site

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    Greenville, North Carolina, 27834, United States

  • Research Site

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    Jacksonville, North Carolina, 28546, United States

  • Research Site

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    Kinston, North Carolina, 28501, United States

  • Research Site

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    Winston-Salem, North Carolina, 27103, United States

  • Research Site

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    Winston-Salem, North Carolina, 27157, United States

  • Research Site

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    Cincinnati, Ohio, 45246, United States

  • Research Site

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    Columbus, Ohio, 43210, United States

  • Research Site

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    Butler, Pennsylvania, 16001, United States

  • Research Site

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    Exton, Pennsylvania, 19341, United States

  • Research Site

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    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

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    Anderson, South Carolina, 29621, United States

  • Research Site

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    Columbia, South Carolina, 29203, United States

  • Research Site

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    Orangeburg, South Carolina, 29118, United States

  • Research Site

    RECRUITING

    Spartanburg, South Carolina, 29306, United States

  • Research Site

    NOT_YET_RECRUITING

    Chattanooga, Tennessee, 37404, United States

  • Research Site

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Research Site

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    Conroe, Texas, 77384, United States

  • Research Site

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    Dallas, Texas, 75234, United States

  • Research Site

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    Dallas, Texas, 75235, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77054, United States

  • Research Site

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    Mesquite, Texas, 75149, United States

  • Research Site

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    Pearland, Texas, 77584, United States

  • Research Site

    RECRUITING

    San Antonio, Texas, 78212, United States

  • Research Site

    WITHDRAWN

    Alexandria, Virginia, 22311, United States

  • Research Site

    NOT_YET_RECRUITING

    Norfolk, Virginia, 23510, United States

  • Research Site

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Research Site

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    Birmingham, B15 2WB, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    Leicester, Le5 4PW, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    Liverpool, L22 0LG, United Kingdom

  • Research Site

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    London, NW3 2QG, United Kingdom

  • Research Site

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    London, SE1 9RT, United Kingdom

  • Research Site

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    London, SE5 8AZ, United Kingdom

  • Research Site

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    London, SM5 1AA, United Kingdom

  • Research Site

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    London, SW17 0QT, United Kingdom

  • Research Site

    RECRUITING

    London, SW7 2AZ, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    Manchester, M13 9WL, United Kingdom

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