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Tests treatment safety and results for APOL1-Mediated Kidney Disease
Official title Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease
ClinicalTrials.gov ID: NCT06824987
What this study is testing
What is AZD2373-Arm 1?
AZD2373-Arm 1 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for apol1-mediated kidney disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age: Male and female participants of African descent (including, but not limited to, Black, Black African, Black Caribbean, African American...
- 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...
- 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...
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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:
- 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...
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- 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
- Orlando, Florida, United States
- Pompano Beach, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Columbus, Georgia, United States
- Duluth, Georgia, United States
- Hinesville, Georgia, United States
+ 56 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 70 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.