A Phase 2 Study of MZE829 in Adults with APOL1 Kidney Disease

Maze Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Proteinuric Kidney Disease

Treatments: Drug: MZE829

Study type: Interventional

Funder types: Industry

Identifiers

NCT06830629

MZE829-201

Details and patient eligibility

About

This is purpose of this study is to evaluate the safety, tolerability, and effect on Albuminuria of MZE829 in Adults with APOL1 Kidney Disease

Full description

An open-label Phase 2 study is designed to evaluate the safety, tolerability, and effect on Albuminuria of MZE829 in Adults with Proteinuric Chronic Kidney Disease and the APOL1 High Risk Genotype.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• APOL1 high risk genotype of G1/G1, G2/G2, or G1/G2
• Chronic kidney disease with persistent albuminuria

Key Exclusion Criteria:

• Organ or bone marrow transplantation
• History of cancer within past 2 years, excepted for treated non-melanoma skin cancer, stage 0 cervical cancer, or stage 1 prostate cancer
• Conditions that may alter drug absorption, e.g., history of bariatric surgery
• Type I diabetes
• Pregnant or currently nursing

Other inclusion/exclusion criteria defined in protocol apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

MZE829

Experimental group

Description:

Cohort 1: Chronic kidney disease with concurrent diabetes Cohort 2: Chronic kidney disease without concurrent diabetes

Treatment:

Drug: MZE829