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Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease

RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: APOL1-Mediated Kidney Disease

Interventions: AZD2373-Arm 1, AZD2373-Arm 2, Placebo, APOL1 Genotyping Clinical Trial Assay

Countries: United States, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (89)

Alabaster, Alabama, United States
Birmingham, Alabama, United States
Irondale, Alabama, United States
Surprise, Arizona, United States
Beverly Hills, California, United States
Concord, California, United States
Fremont, California, United States
Gardena, California, United States
Los Angeles, California, United States
Valencia, California, United States
Boca Raton, Florida, United States
Brandon, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pompano Beach, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Augusta, Georgia, United States
Augusta, Georgia, United States
Columbus, Georgia, United States
Columbus, Georgia, United States
Duluth, Georgia, United States
Hinesville, Georgia, United States
Lawrenceville, Georgia, United States
Macon, Georgia, United States
Macon, Georgia, United States
Marietta, Georgia, United States
Savannah, Georgia, United States
Stockbridge, Georgia, United States
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