2024-517525-10-00RecruitingPhase 2
An Open-Label Phase 2 Study to Evaluate the Safety, Tolerability, and Effect on Albuminuria of MZE829 in Adults with Proteinuric Chronic Kidney Disease and the APOL1 High Risk Genotype
Maze Therapeutics Inc.4 sites in 1 country14 target enrollmentStarted: June 25, 2025Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 14
- Locations
- 4
- Primary Endpoint
- Safety and tolerability based on incidence of adverse events (AEs), and changes in vital signs, clinical laboratory assessments, 12-lead electrocardiograms (ECGs)
Study Overview
Brief Summary
To evaluate the safety and tolerability of MZE829 in adults with proteinuric APOL1 kidney disease
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 to 68 years of age (inclusive) at the time of signing the informed consent
- •Being of recent African descent (e.g., African American, Afro-Caribbean, Afro-Latinx, or African ancestry), regardless of current racial or self-identification
- •Body mass index (BMI) of 18 to ≤45 kg/m2 and total body weight of ≥40 kg
- •Confirmed APOL1 high risk genotype of G1/G1, G2/G2, or G1/G2
- •Diagnosis of chronic kidney disease with persistent high urine albuminuria
- •Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 at Screening based on the Chronic Kidney Disease Epidemiology Collaboration (2021 CKD-EPI Creatinine-Cystatin C) equation
Exclusion Criteria
- •Any condition that in the opinion of the Investigator would interfere with the evaluation of the investigational product or lead to increased risk of harm
- •Use of any potent immunosuppressants within 5 PK half-lives or 12 weeks prior to Screening, whichever is longer
- •Use of oral corticosteroids equivalent to prednisone >10 mg/day for more than 1 day or any use of systemic corticosteroids equivalent to prednisone >10 mg within approximately 8 weeks prior to Screening
- •Clinically significant abnormal laboratory test results with the exception of abnormalities considered by the Investigator to be the result of underlying disease.
- •Clinically significant abnormal Screening ECG, including but not limited to QTcF >450 ms or history of QT interval prolongation
Outcomes
Primary Outcomes
Safety and tolerability based on incidence of adverse events (AEs), and changes in vital signs, clinical laboratory assessments, 12-lead electrocardiograms (ECGs)
Safety and tolerability based on incidence of adverse events (AEs), and changes in vital signs, clinical laboratory assessments, 12-lead electrocardiograms (ECGs)
Secondary Outcomes
No secondary outcomes reported
Investigators
Maze Clinical Lead
Scientific
Maze Therapeutics Inc.
Study Sites (4)
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