APOL1-Mediated Kidney DiseasePhase 2APPRECIATENCT06824987
Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease
A Phase 2 study testing AZD2373-Arm 1, AZD2373-Arm 2 and APOL1 Genotyping Clinical Trial Assay in people with APOL1-Mediated Kidney Disease, run by AstraZeneca at 96 sites in 2 countries.
Trial summary
The purpose of this study is to assess the efficacy and safety of AZD2373 in participants diagnosed with APOL1-Mediated Kidney Disease (AMKD) who are homozygotes or compound heterozygotes for APOL1 high-risk genotypes (G1 and G2). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- APOL1-Mediated Kidney Disease
- What is being tested?
- AZD2373-Arm 1, AZD2373-Arm 2 and APOL1 Genotyping Clinical Trial Assay
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 96 sitesin 2 countries
- Study dates
- 5 Mar 2025to 4 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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:
- Current or past use of insulin for more than 3 months and/or any maintenance therapy with insulin within 2 months of screening.
- Screening Haemoglobin A1c > 8.0%
- 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.
Trial locations and contacts
96 sites in 2 countries.
96 sites in 2 countries
United States86 sites
Research Site
Alabaster, Alabama, 35007
Research Site
Anderson, South Carolina, 29621
Research Site
Atlanta, Georgia, 30322
Research Site
Augusta, Georgia, 30904
Research Site
Augusta, Georgia, 30909
Research Site
Augusta, Georgia, 30912
Research Site
Baton Rouge, Louisiana, 70808
Research Site
Bethesda, Maryland, 20889
Research Site
Beverly Hills, California, 90211
Research Site
Birmingham, Alabama, 35205
Research Site
Boca Raton, Florida, 33487
Research Site
Boston, Massachusetts, 02114
Research Site
Brandon, Florida, 33511
Research Site
Bridgeville, Pennsylvania, 15017
Research Site
Brooklyn, New York, 11203
Research Site
Brooklyn, New York, 11221
Research Site
Butler, Pennsylvania, 16001
Research Site
Cary, North Carolina, 27511
Research Site
Chattanooga, Tennessee, 37404
Research Site
Chicago, Illinois, 60612
Research Site
Chicago, Illinois, 60643
Research Site
Cincinnati, Ohio, 45246
Research Site
Columbia, South Carolina, 29203
Research Site
Columbus, Georgia, 31901
Research Site
Columbus, Georgia, 31904
Research Site
Columbus, Mississippi, 39705
Research Site
Columbus, Ohio, 43210
Research Site
Concord, California, 94520
Research Site
Conroe, Texas, 77304
Research Site
Conroe, Texas, 77384
Research Site
Dallas, Texas, 75234
Research Site
Dallas, Texas, 75235
Research Site
Duluth, Georgia, 30096
Research Site
Durham, North Carolina, 27705
Research Site
Exton, Pennsylvania, 19341
Research Site
Fayetteville, North Carolina, 28304
Research Site
Fremont, California, 94538
Research Site
Gardena, California, 90247
Research Site
Gastonia, North Carolina, 28054
Research Site
Greenville, North Carolina, 27834
Research Site
Hinesville, Georgia, 31313
Research Site
Hinsdale, Illinois, 60521
Research Site
Houston, Texas, 77054
Research Site
Irondale, Alabama, 35210
Research Site
Jacksonville, North Carolina, 28546
Research Site
Katy, Texas, 77450
Research Site
Kinston, North Carolina, 28501
Research Site
Lafayette, Louisiana, 70508
Research Site
Lansing, Michigan, 48911
Research Site
Laurelton, New York, 11413
Research Site
Lawrenceville, Georgia, 30046
Research Site
Los Angeles, California, 90095
Research Site
Macon, Georgia, 31210
Research Site
Macon, Georgia, 31217
Research Site
Marietta, Georgia, 30067
Research Site
Mesquite, Texas, 75149
Research Site
Miami, Florida, 33126
Research Site
Miami, Florida, 33173
Research Site
Minneapolis, Minnesota, 55455
Research Site
Nashville, Tennessee, 37232
Research Site
New Orleans, Louisiana, 70112
Research Site
New York, New York, 10010
Research Site
Norfolk, Virginia, 23510
Research Site
Orangeburg, South Carolina, 29118
Research Site
Orlando, Florida, 32808
Research Site
Pearland, Texas, 77584
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Pompano Beach, Florida, 33060
Research Site
Portsmouth, Virginia, 23708
Research Site
Potomac, Maryland, 20854
Research Site
Richmond, Virginia, 23298
Research Site
Rockford, Illinois, 61107
Research Site
Rockville Centre, New York, 11570
Research Site
Roseville, Michigan, 48066
Research Site
San Antonio, Texas, 78212
Research Site
Savannah, Georgia, 31406
Research Site
Shreveport, Louisiana, 71103
Research Site
Spartanburg, South Carolina, 29306
Research Site
Stockbridge, Georgia, 30281
Research Site
Surprise, Arizona, 85374
Research Site
The Bronx, New York, 10461
Research Site
Tupelo, Mississippi, 38801
Research Site
Valencia, California, 91355
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Winston-Salem, North Carolina, 27157
Research Site
Worcester, Massachusetts, 01608
United Kingdom10 sites
Research Site
Birmingham, B15 2WB
Research Site
Leicester, Le5 4PW
Research Site
Liverpool, L22 0LG
Research Site
London, NW3 2QG
Research Site
London, SE1 9RT
Research Site
London, SE5 8AZ
Research Site
London, SM5 1AA
Research Site
London, SW17 0QT
Research Site
London, SW7 2AZ
Research Site
Manchester, M13 9WL
About this study
Official title: Phase 2b Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of AZD2373 in Participants With APOL1-Mediated Kidney Disease (APPRECIATE)
The purpose of this study is to assess the efficacy and safety of AZD2373 in participants diagnosed with APOL1-Mediated Kidney Disease (AMKD) who are homozygotes or compound heterozygotes for APOL1 high-risk genotypes (G1 and G2). The primary hypothesis to be evaluated is that AZD2373, compared with placebo, will result in a greater reduction in UACR as assessed by the relative change from Baseline in UACR at Week 30.
Read the detailed description
This is a Phase 2b study to assess efficacy and safety of AZD2373 involving 3 study treatment arms in Part A and 2 study treatment arms in Part B where participants and study personnel including study investigators are blinded to the assigned treatment.
Participants with 300 mg/g or greater UACR and eGFR ≥ 25mL/min/1.73m2 will be recruited into the study. Participants on kidney replacement therapy (dialysis or kidney transplant) or any other organ transplant will be excluded.
The study will have Part A and Part B. Part A (n = 96) will have a 1:1:1 randomization of participants to subgroups receiving weekly subcutaneous injections of 50 mg AZD2373, 150 mg AZD2373, and placebo. Part B (n = 40) will have a 4:1 randomization of participants to subgroups receiving every other week subcutaneous injections of 150 mg or placebo. Part B will begin after Part A is completely enrolled.
Both Part A and Part B will have same participant criteria and schedules. The SoA and visit schedule will not change for Part B.
All participants will remain in the study on treatment until the last participant has completed 30 weeks of treatment. The treatment duration will be up to minimum of 30 weeks of study treatment.
All participants will have the opportunity to enter the OLE study.
- Conditions
- APOL1-Mediated Kidney Disease
- Being tested
- AZD2373-Arm 1, AZD2373-Arm 2, Placebo, APOL1 Genotyping Clinical Trial Assay
- Keywords
- APOL1-Mediated Kidney Disease, AZD2373
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2373-Arm 1Combination product
Accessorized Pre-Filled Syringe (Solution for injection)
AZD2373-Arm 2Combination product
Accessorized Pre-Filled Syringe (Solution for injection)
PlaceboCombination product
Accessorized Pre-Filled Syringe (Solution for injection).
APOL1 Genotyping Clinical Trial AssayDevice
The APOL1 Genotyping Clinical Trial Assay, an investigational use only qualitative Polymerase Chain Reaction invitro diagnostic assay, discriminates between the rs73885319 G1(S342G) and rs71785313 G2 genotypes within the APOL1 gene from DNA extracted from whole blood.
| Study group | Role | What they receive |
|---|---|---|
| Part A - Placebo group | Placebo comparator | Participants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose. Receives: Combination Product: Placebo; Device: APOL1 Genotyping Clinical Trial Assay |
| Part A - AZD2373 - Arm 1 | Experimental | Participants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose. Receives: Combination Product: AZD2373-Arm 1; Device: APOL1 Genotyping Clinical Trial Assay |
| Part A - AZD2373 - Arm 2 | Experimental | Participants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose. Receives: Combination Product: AZD2373-Arm 2; Device: APOL1 Genotyping Clinical Trial Assay |
| Part B - AZD2373 Arm 1 | Experimental | Participants will be randomized at a 4:1 ratio to 2 study treatment arms. Participants will receive SC injection of the assigned dose Receives: Combination Product: AZD2373-Arm 2; Device: APOL1 Genotyping Clinical Trial Assay |
| Part B - Placebo group | Placebo comparator | Participants will be randomized at a 4:1 ratio to 2 study treatment arms. Participants will receive SC injection of the assigned dose Receives: Combination Product: Placebo; Device: APOL1 Genotyping Clinical Trial Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in Urine Albumin-Creatinine Ratio (UACR)
To assess the effect of AZD2373 versus placebo in reducing albuminuria
Measured: From Baseline at Week 30
Secondary outcomes (9)
Relative change in Urine Albumin-Creatinine Ratio (UACR)
To assess the effect of AZD2373 versus placebo in reducing albuminuria
Measured: From Baseline at the End of Treatment (Until the last participant completes Week 30)
Relative change in Urine Protein-Creatinine Ratio (UPCR)
To assess the effect of AZD2373 versus placebo in reducing proteinuria
Measured: From Baseline at Week 30
Relative change in Urine Protein-Creatinine Ratio (UPCR)
To assess the effect of AZD2373 versus placebo in reducing proteinuria
Measured: From Baseline at the End of Treatment (Until the last participant completes Week 30)
Proportion of participants achieving a 45% or greater reduction in Urine Albumin-Creatinine Ratio (UACR)
To assess the proportion of participants achieving a 45% or greater Urine Albumin-Creatinine Ratio (UACR) reduction by treatment
Measured: From Baseline at Week 30
Proportion of participants achieving a 45% or greater reduction in Urine Albumin-Creatinine Ratio (UACR)
To assess the proportion of participants achieving a 45% or greater Urine Albumin-Creatinine Ratio (UACR) reduction by treatment
Measured: From Baseline at the End of Treatment (Until the last participant completes Week 30)
eGFR slope
To assess pooled AZD2373 doses versus placebo on eGFR change
Measured: From Baseline at the End of Treatment (Until the last participant completes Week 30)
Incidence of development of ADA and ADA titer (if participants are ADA-positive)
To evaluate the immunogenicity of AZD2373
Measured: During treatment (up to Week 30) and follow-up (up to 12 weeks)
Plasma concentration
To evaluate the PK of AZD2373
Measured: From Baseline at the End of Treatment (Until the last participant completes Week 30)
Adverse Events (AEs), Serious Adverse Events (SAEs), and Drug Adverse Events (DAEs).
To assess the safety and tolerability of ranging doses of AZD2373. These events will be collected according to the timepoints specified in the schedule of assessments, starting from the time of signing the Informed Consent Form (ICF).
Measured: From baseline at the End of Treatment (Until the last participant completes Week 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start5 Mar 2025
- Primary completion4 Oct 2027 (estimated)
- Study completion4 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for APOL1-Mediated Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A: Participants will be randomized at a 1:1:1 ratio to 3 study treatment arms: * Placebo group * AZD2373 - Arm 1 * AZD2373 - Arm 2 Part B: Participants will be randomized at a 4:1 ratio to 2 study treatment arms: * AZD2373 - Arm 1 * Placebo group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824987
- Sponsor's protocol ID
- D6800C00005
- Acronym
- APPRECIATE
- Status last verified
- Oct 2026
- First submitted
- 24 Jan 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of AZD2373 in Participants With APOL1-Mediated Kidney Disease (APPRECIATE)
- ClinicalTrials.gov ID
- NCT06824987
- Acronym / sponsor ID
- APPRECIATE / D6800C00005
- Conditions
- APOL1-Mediated Kidney Disease
- Keywords
- APOL1-Mediated Kidney Disease, AZD2373
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 4 Oct 2027 (estimated)
- Study completion
- 4 Oct 2027 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of AZD2373 in participants diagnosed with APOL1-Mediated Kidney Disease (AMKD) who are homozygotes or compound heterozygotes for APOL1 high-risk genotypes (G1 and G2). The primary hypothesis to be evaluated is that AZD2373, compared with placebo, will result in a greater reduction in UACR as assessed by the relative change from Baseline in UACR at Week 30.
Detailed description
This is a Phase 2b study to assess efficacy and safety of AZD2373 involving 3 study treatment arms in Part A and 2 study treatment arms in Part B where participants and study personnel including study investigators are blinded to the assigned treatment.
Participants with 300 mg/g or greater UACR and eGFR ≥ 25mL/min/1.73m2 will be recruited into the study. Participants on kidney replacement therapy (dialysis or kidney transplant) or any other organ transplant will be excluded.
The study will have Part A and Part B. Part A (n = 96) will have a 1:1:1 randomization of participants to subgroups receiving weekly subcutaneous injections of 50 mg AZD2373, 150 mg AZD2373, and placebo. Part B (n = 40) will have a 4:1 randomization of participants to subgroups receiving every other week subcutaneous injections of 150 mg or placebo. Part B will begin after Part A is completely enrolled.
Both Part A and Part B will have same participant criteria and schedules. The SoA and visit schedule will not change for Part B.
All participants will remain in the study on treatment until the last participant has completed 30 weeks of treatment. The treatment duration will be up to minimum of 30 weeks of study treatment.
All participants will have the opportunity to enter the OLE study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Part A: Participants will be randomized at a 1:1:1 ratio to 3 study treatment arms: * Placebo group * AZD2373 - Arm 1 * AZD2373 - Arm 2 Part B: Participants will be randomized at a 4:1 ratio to 2 study treatment arms: * AZD2373 - Arm 1 * Placebo group
| Arm | Type | Receives |
|---|---|---|
| Part A - Placebo group | Placebo comparator | Combination Product: Placebo, Device: APOL1 Genotyping Clinical Trial AssayParticipants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose. |
| Part A - AZD2373 - Arm 1 | Experimental | Combination Product: AZD2373-Arm 1, Device: APOL1 Genotyping Clinical Trial AssayParticipants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose. |
| Part A - AZD2373 - Arm 2 | Experimental | Combination Product: AZD2373-Arm 2, Device: APOL1 Genotyping Clinical Trial AssayParticipants will be randomized at a 1:1:1 ratio to 3 study treatment arms. Participants will receive SC injection of the assigned dose. |
| Part B - AZD2373 Arm 1 | Experimental | Combination Product: AZD2373-Arm 2, Device: APOL1 Genotyping Clinical Trial AssayParticipants will be randomized at a 4:1 ratio to 2 study treatment arms. Participants will receive SC injection of the assigned dose |
| Part B - Placebo group | Placebo comparator | Combination Product: Placebo, Device: APOL1 Genotyping Clinical Trial AssayParticipants will be randomized at a 4:1 ratio to 2 study treatment arms. Participants will receive SC injection of the assigned dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD2373-Arm 1Accessorized Pre-Filled Syringe (Solution for injection) | Combination product | Part A - AZD2373 - Arm 1 |
| AZD2373-Arm 2Accessorized Pre-Filled Syringe (Solution for injection) | Combination product | Part A - AZD2373 - Arm 2, Part B - AZD2373 Arm 1 |
| PlaceboAccessorized Pre-Filled Syringe (Solution for injection). | Combination product | Part A - Placebo group, Part B - Placebo group |
| APOL1 Genotyping Clinical Trial AssayThe APOL1 Genotyping Clinical Trial Assay, an investigational use only qualitative Polymerase Chain Reaction invitro diagnostic assay, discriminates between the rs73885319 G1(S342G) and rs71785313 G2 genotypes within the APOL1 gene from DNA extracted from whole blood. | Device | Part A - AZD2373 - Arm 1, Part A - AZD2373 - Arm 2, Part A - Placebo group, Part B - AZD2373 Arm 1, Part B - Placebo group |
Primary outcome
Relative change in Urine Albumin-Creatinine Ratio (UACR)
Time frame: From Baseline at Week 30
To assess the effect of AZD2373 versus placebo in reducing albuminuria
9 secondary outcomes
Relative change in Urine Albumin-Creatinine Ratio (UACR)
Time frame: From Baseline at the End of Treatment (Until the last participant completes Week 30)
Relative change in Urine Protein-Creatinine Ratio (UPCR)
Time frame: From Baseline at Week 30
Relative change in Urine Protein-Creatinine Ratio (UPCR)
Time frame: From Baseline at the End of Treatment (Until the last participant completes Week 30)
Proportion of participants achieving a 45% or greater reduction in Urine Albumin-Creatinine Ratio (UACR)
Time frame: From Baseline at Week 30
Proportion of participants achieving a 45% or greater reduction in Urine Albumin-Creatinine Ratio (UACR)
Time frame: From Baseline at the End of Treatment (Until the last participant completes Week 30)
eGFR slope
Time frame: From Baseline at the End of Treatment (Until the last participant completes Week 30)
Incidence of development of ADA and ADA titer (if participants are ADA-positive)
Time frame: During treatment (up to Week 30) and follow-up (up to 12 weeks)
Plasma concentration
Time frame: From Baseline at the End of Treatment (Until the last participant completes Week 30)
Adverse Events (AEs), Serious Adverse Events (SAEs), and Drug Adverse Events (DAEs).
Time frame: From baseline at the End of Treatment (Until the last participant completes Week 30)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
96 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD2373-Arm 1, AZD2373-Arm 2 and APOL1 Genotyping Clinical Trial Assay in people with APOL1-Mediated Kidney Disease, run by AstraZeneca at 96 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in Urine Albumin-Creatinine Ratio (UACR) (time frame: From Baseline at Week 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.