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Phase 2b Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of AZD2373 in Participants With APOL1-Mediated Kidney Disease (APPRECIATE)

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.

CT.gov Identifier

NCT06824987

EudraCT Identifier

N/A

CTIS:

N/A

Collaborator

N/A

Study Contact Information

+44 20 3749 5000

Recruiting

Study Details

Diseases

APOL1 Mediated Kidney Disease (AMKD)

Study Drug

Opemalirsen

Genes

APOL1

Study Dates

Mar 2025 - Aug 2027

Sex

Female & Male

Age

18 - 65 Years

Inclusion and Exclusion Criteria

Inclusion Criteria:

* Age: Male and female participants aged 18 to 65 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.
* Acute coronary syndrome/Acute myocardial infraction +/- coronary intervention with Percutaneous coronary intervention or Coronary artery bypass grafting within 6 months.
* Transient ischaemic attack/ stroke within 3 months.
* High 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 any past use of insulin
2. Screening Haemoglobin A1c > 8.0%
3. Receiving more than one oral anti-hyperglycaemic agent (excluding SGLT inhibitors which can be taken in addition to one other oral 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.

Protocol Summary

Study Locations

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