Actively Recruiting
Phase 2b Multicentre, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease
Led by AstraZeneca · Updated on 2025-10-29
96
Participants Needed
77
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of AZD2373 in adults aged 18 to 65 years who have APOL1-Mediated Kidney Disease (AMKD) and carry high-risk APOL1 genotypes (G1 and G2). This Phase 2b study aims to see if AZD2373 can reduce the Urine Albumin-Creatinine Ratio (UACR) compared to placebo, with the main focus on the relative change in UACR at 30 weeks. Participants with certain kidney function levels and albuminuria will be included, while those on dialysis or with other organ transplants will be excluded. Participants will be randomly assigned to one of three groups receiving different doses of AZD2373 or a placebo, all given as subcutaneous injections. The study is blinded, meaning neither participants nor study staff know who receives which treatment. Treatment will last for at least 30 weeks, with about 96 participants total, divided evenly among the three groups. During the study, participants will undergo regular urine tests to measure albumin and protein levels, kidney function assessments, and monitoring for any adverse events. Blood samples will be collected to check drug levels and immune responses. These evaluations will continue until the last participant completes the 30-week treatment period, ensuring thorough assessment of AZD2373's impact and safety.
CONDITIONS
Brief 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; G2/G2)
- Urine albumin-creatinine ratio (UACR) of 300 mg/g or greater based on 3 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 during the study
- Ability to provide 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
- Recent acute coronary events or interventions within 6 months
- Transient ischemic attack or stroke within 3 months
- Untreated high-grade AV block or serious sinus node dysfunction
- History of ventricular arrhythmias needing treatment
- Type 2 diabetes with current or past insulin use, HbA1c over 8.0%, or use of more than one oral anti-hyperglycemic agent (excluding SGLT inhibitors)
- Current kidney replacement therapy or any organ transplant
- History or evidence of autoimmune glomerular diseases
- Other non-APOL1 related kidney diseases such as polycystic kidney disease or congenital anomalies
- History of diagnosed bleeding disorders or major unexplained bleeding events
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to minimum of 30 weeks
Participants receive subcutaneous injections of the assigned dose of AZD2373 or placebo. Treatment continues for a minimum of 30 weeks.
Regular visits during treatment period
Duration - Up to 12 weeks
Participants are monitored for safety including development of anti-drug antibodies and other adverse events for up to 12 weeks after treatment ends.
Visits during follow-up period
Trial Site Locations
Total: 77 locations
1
Research Site
Alabaster, Alabama, United States, 35007
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2
Research Site
Birmingham, Alabama, United States, 35205
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3
Research Site
Irondale, Alabama, United States, 35210
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4
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Beverly Hills, California, United States, 90211
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5
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Gardena, California, United States, 90247
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6
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Los Angeles, California, United States, 90095
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7
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Valencia, California, United States, 91355
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8
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Brandon, Florida, United States, 33511
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9
Research Site
Miami, Florida, United States, 33126
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10
Research Site
Miami, Florida, United States, 33173
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11
Research Site
Orlando, Florida, United States, 32808
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12
Research Site
Pompano Beach, Florida, United States, 33060
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13
Research Site
Atlanta, Georgia, United States, 30322
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14
Research Site
Augusta, Georgia, United States, 30909
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15
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Augusta, Georgia, United States, 30912
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16
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Columbus, Georgia, United States, 31901
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17
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Columbus, Georgia, United States, 31904
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18
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Duluth, Georgia, United States, 30096
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19
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Hinesville, Georgia, United States, 31313
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20
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Lawrenceville, Georgia, United States, 30046
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21
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Macon, Georgia, United States, 31210
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22
Research Site
Macon, Georgia, United States, 31217
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23
Research Site
Marietta, Georgia, United States, 30067
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24
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Savannah, Georgia, United States, 31406
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25
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Stockbridge, Georgia, United States, 30281
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26
Research Site
Chicago, Illinois, United States, 60612
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27
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Hinsdale, Illinois, United States, 60521
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28
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Lafayette, Louisiana, United States, 70508
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29
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New Orleans, Louisiana, United States, 70112
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30
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Bethesda, Maryland, United States, 20889
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31
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Potomac, Maryland, United States, 20854
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32
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Boston, Massachusetts, United States, 02114
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33
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Roseville, Michigan, United States, 48066
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34
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Minneapolis, Minnesota, United States, 55455
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35
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Tupelo, Mississippi, United States, 38801
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36
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Brooklyn, New York, United States, 11203
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37
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Brooklyn, New York, United States, 11221
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38
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Laurelton, New York, United States, 11413
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39
Research Site
New York, New York, United States, 10010
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40
Research Site
Cary, North Carolina, United States, 27511
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41
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Durham, North Carolina, United States, 27705
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42
Research Site
Fayetteville, North Carolina, United States, 28304
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43
Research Site
Gastonia, North Carolina, United States, 28054
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44
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Greenville, North Carolina, United States, 27834
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45
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Jacksonville, North Carolina, United States, 28546
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46
Research Site
Kinston, North Carolina, United States, 28501
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47
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Winston-Salem, North Carolina, United States, 27103
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48
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Winston-Salem, North Carolina, United States, 27157
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49
Research Site
Cincinnati, Ohio, United States, 45246
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50
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Columbus, Ohio, United States, 43210
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51
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Philadelphia, Pennsylvania, United States, 19104
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52
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Anderson, South Carolina, United States, 29621
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53
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Columbia, South Carolina, United States, 29203
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54
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Orangeburg, South Carolina, United States, 29118
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55
Research Site
Spartanburg, South Carolina, United States, 29306
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56
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Chattanooga, Tennessee, United States, 37404
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57
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Nashville, Tennessee, United States, 37232
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58
Research Site
Conroe, Texas, United States, 77384
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59
Research Site
Dallas, Texas, United States, 75234
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60
Research Site
Dallas, Texas, United States, 75235
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61
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Houston, Texas, United States, 77054
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62
Research Site
Mesquite, Texas, United States, 75149
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63
Research Site
Pearland, Texas, United States, 77584
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64
Research Site
San Antonio, Texas, United States, 78212
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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
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68
Research Site
Birmingham, United Kingdom, B15 2WB
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69
Research Site
Leicester, United Kingdom, Le5 4PW
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70
Research Site
Liverpool, United Kingdom, L22 0LG
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71
Research Site
London, United Kingdom, NW3 2QG
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72
Research Site
London, United Kingdom, SE1 9RT
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73
Research Site
London, United Kingdom, SE5 8AZ
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74
Research Site
London, United Kingdom, SM5 1AA
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75
Research Site
London, United Kingdom, SW17 0QT
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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
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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