Phase
Condition
N/ATreatment
Placebo
AZD2373-Arm 2
APOL1 Genotyping Clinical Trial Assay
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age: Male and female participants aged 18 to 65 years, inclusive at the time ofinformed consent.
Participants who have high-risk APOL1 genotype (G1/G1; G1/G2; G2/G2). The screeningperiod can be extended if there are delays related to the shipment, handling, orprocessing 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 assessedfor 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 regulationsregarding the methods of contraception for those participating in clinical studies.
Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the ICF and in this protocol.
Exclusion
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 atsteady state, and preferably when they have taken their BP medications that sameday).
QTcF > 470 ms.
Acute coronary syndrome/Acute myocardial infraction +/- coronary intervention withPercutaneous coronary intervention or Coronary artery bypass grafting within 6months.
Transient ischaemic attack/ stroke within 3 months.
High second to third degree AV block or clinically significant sinus nodedysfunction untreated with pacemaker.
A history of ventricular arrhythmias requiring treatment.
Participants with Type 2 diabetes mellitus must be excluded if ANY of the followingconditions are present:
Current or any past use of insulin
Screening Haemoglobin A1c > 8.0%
Receiving more than one oral anti-hyperglycaemic agent (excluding SGLTinhibitors which can be taken in addition to one other oral anti-hyperglycaemicagent).
Participant on kidney replacement therapy (dialysis or kidney transplant) or anyother organ transplant.
History or serologic evidence of autoimmune-mediated glomerular disease includingbut not limited to: lupus nephritis (positive lupus serology), ANCA associatedvasculitis (antineutrophil cytoplasmic antibody), membranous nephropathy (anti-phospholipase A2 receptor antibody or other autoantibody associated withmembranous 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 ofthe kidney and urinary tract.
History of a diagnosed coagulopathy, a major unexplained bleeding event, or otherhigh-risk bleeding diathesis.
Study Design
Study Description
Connect with a study center
Research Site
Leicester, Le5 4PW
United KingdomSite Not Available
Research Site
Liverpool, L22 0LG
United KingdomSite Not Available
Research Site
London, SM5 1AA
United KingdomSite Not Available
Research Site
Manchester, M13 9WL
United KingdomSite Not Available
Research Site
Alabaster, Alabama 35007
United StatesActive - Recruiting
Research Site
Birmingham, Alabama 35205
United StatesActive - Recruiting
Research Site
Irondale, Alabama 35210
United StatesActive - Recruiting
Research Site
Gardena, California 90247
United StatesSite Not Available
Research Site
Los Angeles, California 90095
United StatesSite Not Available
Research Site
Northridge, California 91324
United StatesActive - Recruiting
Research Site
Valencia, California 91355
United StatesActive - Recruiting
Research Site
Brandon, Florida 33511
United StatesSite Not Available
Research Site
Miami, Florida 33126
United StatesSite Not Available
Research Site
Orlando, Florida 32808
United StatesSite Not Available
Research Site
Atlanta, Georgia 30322
United StatesSite Not Available
Research Site
Lawrenceville, Georgia 30046
United StatesSite Not Available
Research Site
Macon, Georgia 31217
United StatesActive - Recruiting
Research Site
Hinsdale, Illinois 60521
United StatesSite Not Available
Research Site
Lafayette, Louisiana 70508
United StatesSite Not Available
Research Site
Bethesda, Maryland 20889
United StatesSite Not Available
Research Site
Potomac, Maryland 20854
United StatesSite Not Available
Research Site
Boston, Massachusetts 02114
United StatesSite Not Available
Research Site
Roseville, Michigan 48066
United StatesActive - Recruiting
Research Site
Tupelo, Mississippi 38801
United StatesSite Not Available
Research Site
Brooklyn, New York 11221
United StatesSite Not Available
Research Site
Laurelton, New York 11413
United StatesActive - Recruiting
Research Site
Fayetteville, North Carolina 28304
United StatesSite Not Available
Research Site
Greenville, North Carolina 27834
United StatesSite Not Available
Research Site
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
Research Site
Cincinnati, Ohio 45246
United StatesSite Not Available
Research Site
Anderson, South Carolina 29621
United StatesSite Not Available
Research Site
Columbia, South Carolina 29203
United StatesSite Not Available
Research Site
Orangeburg, South Carolina 29118
United StatesActive - Recruiting
Research Site
Spartanburg, South Carolina 29306
United StatesActive - Recruiting
Research Site
Chattanooga, Tennessee 37404
United StatesSite Not Available
Research Site
Dallas, Texas 75235
United StatesSite Not Available
Research Site
Mesquite, Texas 75149
United StatesSite Not Available
Research Site
Pearland, Texas 77584
United StatesActive - Recruiting
Research Site
San Antonio, Texas 78212
United StatesSite Not Available
Research Site
Alexandria, Virginia 22311
United StatesSite Not Available
Research Site
Norfolk, Virginia 23510
United StatesSite Not Available
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