Actively Recruiting
Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease
Led by AstraZeneca · Updated on 2025-10-29
96
Participants Needed
77
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 to 65 years at the time of consent
- High-risk APOL1 genotype (G1/G1, G1/G2, or G2/G2)
- Geometric mean urine albumin-creatinine ratio (UACR) of 300 mg/g or greater based on three consecutive first morning urine samples
- Estimated glomerular filtration rate (eGFR) of 25 mL/min/1.73m2 or higher
- Use of contraception consistent with local regulations for clinical study participants
- Able to give signed informed consent and comply with study requirements
You will not qualify if you...
- Diagnosis of Type 1 diabetes mellitus
- Body Mass Index greater than 45 kg/m2
- Systolic blood pressure over 180 mmHg or diastolic blood pressure over 110 mmHg at steady state
- QTcF interval longer than 470 ms
- Acute coronary syndrome or myocardial infarction within 6 months, including related coronary interventions
- Transient ischemic attack or stroke within 3 months
- Untreated high-grade AV block or significant sinus node dysfunction without pacemaker
- History of ventricular arrhythmias requiring treatment
- For Type 2 diabetes patients: current or past insulin use, HbA1c over 8.0%, or use of more than one oral anti-hyperglycemic agent (except SGLT inhibitors in combination with one other agent)
- Currently on kidney replacement therapy (dialysis or kidney transplant) or any other organ transplant
- History or evidence of autoimmune-mediated kidney diseases such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, anti-GBM disease, or IgA nephropathy
- Other causes of kidney disease unrelated to APOL1, including polycystic kidney disease or congenital kidney anomalies
- History of diagnosed bleeding disorders, major unexplained bleeding, or other high-risk bleeding conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 77 locations
1
Research Site
Alabaster, Alabama, United States, 35007
Actively Recruiting
2
Research Site
Birmingham, Alabama, United States, 35205
Actively Recruiting
3
Research Site
Irondale, Alabama, United States, 35210
Actively Recruiting
4
Research Site
Beverly Hills, California, United States, 90211
Actively Recruiting
5
Research Site
Gardena, California, United States, 90247
Actively Recruiting
6
Research Site
Los Angeles, California, United States, 90095
Not Yet Recruiting
7
Research Site
Valencia, California, United States, 91355
Actively Recruiting
8
Research Site
Brandon, Florida, United States, 33511
Actively Recruiting
9
Research Site
Miami, Florida, United States, 33126
Actively Recruiting
10
Research Site
Miami, Florida, United States, 33173
Actively Recruiting
11
Research Site
Orlando, Florida, United States, 32808
Actively Recruiting
12
Research Site
Pompano Beach, Florida, United States, 33060
Actively Recruiting
13
Research Site
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
14
Research Site
Augusta, Georgia, United States, 30909
Actively Recruiting
15
Research Site
Augusta, Georgia, United States, 30912
Not Yet Recruiting
16
Research Site
Columbus, Georgia, United States, 31901
Actively Recruiting
17
Research Site
Columbus, Georgia, United States, 31904
Actively Recruiting
18
Research Site
Duluth, Georgia, United States, 30096
Actively Recruiting
19
Research Site
Hinesville, Georgia, United States, 31313
Actively Recruiting
20
Research Site
Lawrenceville, Georgia, United States, 30046
Actively Recruiting
21
Research Site
Macon, Georgia, United States, 31210
Actively Recruiting
22
Research Site
Macon, Georgia, United States, 31217
Actively Recruiting
23
Research Site
Marietta, Georgia, United States, 30067
Actively Recruiting
24
Research Site
Savannah, Georgia, United States, 31406
Actively Recruiting
25
Research Site
Stockbridge, Georgia, United States, 30281
Actively Recruiting
26
Research Site
Chicago, Illinois, United States, 60612
Not Yet Recruiting
27
Research Site
Hinsdale, Illinois, United States, 60521
Actively Recruiting
28
Research Site
Lafayette, Louisiana, United States, 70508
Actively Recruiting
29
Research Site
New Orleans, Louisiana, United States, 70112
Actively Recruiting
30
Research Site
Bethesda, Maryland, United States, 20889
Actively Recruiting
31
Research Site
Potomac, Maryland, United States, 20854
Actively Recruiting
32
Research Site
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
33
Research Site
Roseville, Michigan, United States, 48066
Actively Recruiting
34
Research Site
Minneapolis, Minnesota, United States, 55455
Not Yet Recruiting
35
Research Site
Tupelo, Mississippi, United States, 38801
Actively Recruiting
36
Research Site
Brooklyn, New York, United States, 11203
Actively Recruiting
37
Research Site
Brooklyn, New York, United States, 11221
Actively Recruiting
38
Research Site
Laurelton, New York, United States, 11413
Actively Recruiting
39
Research Site
New York, New York, United States, 10010
Not Yet Recruiting
40
Research Site
Cary, North Carolina, United States, 27511
Actively Recruiting
41
Research Site
Durham, North Carolina, United States, 27705
Not Yet Recruiting
42
Research Site
Fayetteville, North Carolina, United States, 28304
Actively Recruiting
43
Research Site
Gastonia, North Carolina, United States, 28054
Actively Recruiting
44
Research Site
Greenville, North Carolina, United States, 27834
Actively Recruiting
45
Research Site
Jacksonville, North Carolina, United States, 28546
Actively Recruiting
46
Research Site
Kinston, North Carolina, United States, 28501
Actively Recruiting
47
Research Site
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
48
Research Site
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
49
Research Site
Cincinnati, Ohio, United States, 45246
Actively Recruiting
50
Research Site
Columbus, Ohio, United States, 43210
Actively Recruiting
51
Research Site
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
52
Research Site
Anderson, South Carolina, United States, 29621
Actively Recruiting
53
Research Site
Columbia, South Carolina, United States, 29203
Actively Recruiting
54
Research Site
Orangeburg, South Carolina, United States, 29118
Actively Recruiting
55
Research Site
Spartanburg, South Carolina, United States, 29306
Actively Recruiting
56
Research Site
Chattanooga, Tennessee, United States, 37404
Not Yet Recruiting
57
Research Site
Nashville, Tennessee, United States, 37232
Actively Recruiting
58
Research Site
Conroe, Texas, United States, 77384
Not Yet Recruiting
59
Research Site
Dallas, Texas, United States, 75234
Actively Recruiting
60
Research Site
Dallas, Texas, United States, 75235
Actively Recruiting
61
Research Site
Houston, Texas, United States, 77054
Actively Recruiting
62
Research Site
Mesquite, Texas, United States, 75149
Actively Recruiting
63
Research Site
Pearland, Texas, United States, 77584
Actively Recruiting
64
Research Site
San Antonio, Texas, United States, 78212
Actively Recruiting
65
Research Site
Alexandria, Virginia, United States, 22311
Withdrawn
66
Research Site
Norfolk, Virginia, United States, 23510
Not Yet Recruiting
67
Research Site
Richmond, Virginia, United States, 23298
Not Yet Recruiting
68
Research Site
Birmingham, United Kingdom, B15 2WB
Not Yet Recruiting
69
Research Site
Leicester, United Kingdom, Le5 4PW
Not Yet Recruiting
70
Research Site
Liverpool, United Kingdom, L22 0LG
Not Yet Recruiting
71
Research Site
London, United Kingdom, NW3 2QG
Not Yet Recruiting
72
Research Site
London, United Kingdom, SE1 9RT
Not Yet Recruiting
73
Research Site
London, United Kingdom, SE5 8AZ
Not Yet Recruiting
74
Research Site
London, United Kingdom, SM5 1AA
Not Yet Recruiting
75
Research Site
London, United Kingdom, SW17 0QT
Not Yet Recruiting
76
Research Site
London, United Kingdom, SW7 2AZ
Not Yet Recruiting
77
Research Site
Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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