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Evaluating AZD2373 for Kidney Disease Related to APOL1 Genotypes

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)

Phase 2 Interventional AstraZeneca · NCT06824987

This study is testing a new medication called AZD2373 to see if it can help people with a specific type of kidney disease linked to certain genetic factors.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment96 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations77 sites (Alabaster, Alabama and 76 other locations)
Trial IDNCT06824987 on ClinicalTrials.gov

What this trial studies

This Phase 2b clinical trial aims to assess the safety and efficacy of AZD2373 in participants with APOL1-Mediated Kidney Disease who carry high-risk genotypes. The study involves three treatment arms, including two doses of AZD2373 and a placebo, with participants and investigators blinded to treatment assignments. The primary outcome is the change in urine albumin-to-creatinine ratio (UACR) after 30 weeks of treatment. Approximately 96 participants will be randomized, and those with significant kidney impairment or on kidney replacement therapy will be excluded.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with high-risk APOL1 genotypes and elevated UACR.

Not a fit: Patients with Type 1 diabetes or those on kidney replacement therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve kidney function and health outcomes for patients with APOL1-Mediated Kidney Disease.

How similar studies have performed: While there have been studies on APOL1-related conditions, this specific approach with AZD2373 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / 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.

Where this trial is running

Alabaster, Alabama and 76 other locations

+27 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions APOL1-Mediated Kidney DiseaseAZD2373
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.