MZE829 for APOL1-mediated kidney disease | Proteinuric chronic kidney disease

Inclusion criteria

• {"criterion_text":"- 18 to 68 years of age (inclusive) at the time of signing the informed consent"}
• {"criterion_text":"- Being of recent African descent (e.g., African American, Afro-Caribbean, Afro-Latinx, or African ancestry), regardless of current racial or self-identification"}
• {"criterion_text":"- Body mass index (BMI) of 18 to ≤45 kg/m2 and total body weight of ≥40 kg"}
• {"criterion_text":"- Confirmed APOL1 high risk genotype of G1/G1, G2/G2, or G1/G2"}
• {"criterion_text":"- Diagnosis of chronic kidney disease with persistent high urine albuminuria"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- History of proteinuria"}

Exclusion criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- Use of any potent immunosuppressants within 5 PK half-lives or 12 weeks prior to Screening, whichever is longer"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Clinically significant abnormal laboratory test results with the exception of abnormalities considered by the Investigator to be the result of underlying disease."}
• {"criterion_text":"- Clinically significant abnormal Screening ECG, including but not limited to QTcF >450 ms or history of QT interval prolongation"}

Primary endpoints

• {"endpoint_text":"- Safety and tolerability based on incidence of adverse events (AEs), and changes in vital signs, clinical laboratory assessments, 12-lead electrocardiograms (ECGs)","definition_or_measurement_approach":"Based on incidence of adverse events (AEs), and changes in vital signs, clinical laboratory assessments, 12-lead electrocardiograms (ECGs)"}

Methods

• Documented recruitment arrangements (document: K1_Recruitment arrangements) — recruitment materials exist for patients
• Recruitment material: Patient Brochure (document: K2_Recruitment material_Patient Brochure) and Flyer (document: K2_Recruitment material_Flyer)
• Patient concierge and mobile research nursing support provided (as listed in third party duties for Syneos Health Inc.)

France

Earliest CTIS Part Ii Submission Date

13-06-2025

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

259

Number Of Sites

8

Number Of Participants

14

Primary sponsor

Full Name

Maze Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Syneos Health Inc.

Responsibilities

Codes: 1,10,12,15,5,6,7,8; value: Patient concierge and mobile research nursing

Name

Medidata Solutions Inc.

Responsibilities

Codes: 7

Name

Suvoda LLC

Responsibilities

Codes: 3

Third parties

• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Codes: 1,10,12,15,5,6,7,8; value: Patient concierge and mobile research nursing","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"Codes: 15; value: Cyclosporin A and Tacrolimus EU lab","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"Codes: 15; value: PK 1 lab","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Codes: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Codes: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Precision For Medicine Inc.","duties_or_roles":"Codes: 15,4; value: Plasma and Urine, BM 1-2, PK2, MicroArray Genotyping, Plasma and Urine BM 3-4 lab","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Nephropathology Associates PLC","duties_or_roles":"Codes: 15; value: APOL1 Genotyping","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Codes: 4","organisation_type":"Pharmaceutical company"}