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NCT Number: NCT06830629

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

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

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Key information

Conditions

Proteinuric Kidney Disease

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Créteil, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 active cancer within past 2 years, except 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.

Treatment and study plan

MZE829

Drug

Capsules for oral administration

Primary outcomes

  1. Safety and tolerability as assessed by incidence of adverse events (AEs)

    Time frame: Baseline to Week 12

Secondary outcomes

  1. Percent participants with ≥30% reduction from baseline in UACR at Week 12

    Time frame: Baseline to Week 12

  2. Geometric mean plasma drug concentrations

    Time frame: Baseline to Week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Maze Therapeutics

CONTACT

[email protected]

650-850-5075

Sponsors and collaborators

Lead sponsor

Maze Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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