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

NCT ID: NCT06830629

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-05

Study Completion Date

2026-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Proteinuric Kidney Disease

Keywords

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APOL1-mediated kidney disease (AMKD) APOL1 kidney disease (AKD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MZE829

Cohort 1: Chronic kidney disease with concurrent diabetes

Cohort 2: Chronic kidney disease without concurrent diabetes

Group Type EXPERIMENTAL

MZE829

Intervention Type DRUG

Capsules for oral administration

Interventions

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MZE829

Capsules for oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maze Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Maze Therapeutics

Locations

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Research Site

Decatur, Alabama, United States

Site Status RECRUITING

Research Site

Huntsville, Alabama, United States

Site Status RECRUITING

Research Site

Montgomery, Alabama, United States

Site Status RECRUITING

Research Site

Granada Hills, California, United States

Site Status RECRUITING

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Valencia, California, United States

Site Status RECRUITING

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Bloomfield, Connecticut, United States

Site Status RECRUITING

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Atlantis, Florida, United States

Site Status RECRUITING

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Brandon, Florida, United States

Site Status RECRUITING

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Brooksville, Florida, United States

Site Status RECRUITING

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Hollywood, Florida, United States

Site Status RECRUITING

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Melbourne, Florida, United States

Site Status RECRUITING

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Miami Lakes, Florida, United States

Site Status RECRUITING

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Orlando, Florida, United States

Site Status RECRUITING

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College Park, Georgia, United States

Site Status RECRUITING

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Cordele, Georgia, United States

Site Status RECRUITING

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Macon, Georgia, United States

Site Status RECRUITING

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Savannah, Georgia, United States

Site Status RECRUITING

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Chicago, Illinois, United States

Site Status RECRUITING

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Bowling Green, Kentucky, United States

Site Status RECRUITING

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Louisville, Kentucky, United States

Site Status RECRUITING

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Baltimore, Maryland, United States

Site Status RECRUITING

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Lutherville, Maryland, United States

Site Status RECRUITING

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Oxon Hill, Maryland, United States

Site Status RECRUITING

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Dearborn, Michigan, United States

Site Status RECRUITING

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Flint, Michigan, United States

Site Status RECRUITING

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Pontiac, Michigan, United States

Site Status RECRUITING

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Saint Joseph, Michigan, United States

Site Status RECRUITING

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Shelby, Michigan, United States

Site Status RECRUITING

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Minneapolis, Minnesota, United States

Site Status RECRUITING

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Fayette, Mississippi, United States

Site Status RECRUITING

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Ridgeland, Mississippi, United States

Site Status RECRUITING

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Tupelo, Mississippi, United States

Site Status RECRUITING

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City of Saint Peters, Missouri, United States

Site Status RECRUITING

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St Louis, Missouri, United States

Site Status RECRUITING

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Las Vegas, Nevada, United States

Site Status RECRUITING

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Laurelton, New York, United States

Site Status RECRUITING

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Maspeth, New York, United States

Site Status RECRUITING

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New York, New York, United States

Site Status RECRUITING

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Durham, North Carolina, United States

Site Status RECRUITING

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Greensboro, North Carolina, United States

Site Status RECRUITING

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Shelby, North Carolina, United States

Site Status RECRUITING

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Cincinnati, Ohio, United States

Site Status RECRUITING

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Cleveland, Ohio, United States

Site Status RECRUITING

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Cleveland, Ohio, United States

Site Status RECRUITING

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Columbus, Ohio, United States

Site Status RECRUITING

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Ardmore, Oklahoma, United States

Site Status RECRUITING

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Upland, Pennsylvania, United States

Site Status RECRUITING

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Columbia, South Carolina, United States

Site Status RECRUITING

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Spartanburg, South Carolina, United States

Site Status RECRUITING

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Spartanburg, South Carolina, United States

Site Status RECRUITING

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Chattanooga, Tennessee, United States

Site Status RECRUITING

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Greenville, Texas, United States

Site Status RECRUITING

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Houston, Texas, United States

Site Status RECRUITING

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Houston, Texas, United States

Site Status RECRUITING

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Houston, Texas, United States

Site Status RECRUITING

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McKinney, Texas, United States

Site Status RECRUITING

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San Antonio, Texas, United States

Site Status RECRUITING

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Shenandoah, Texas, United States

Site Status RECRUITING

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Sherman, Texas, United States

Site Status RECRUITING

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Hampton, Virginia, United States

Site Status RECRUITING

Research Site

Norfolk, Virginia, United States

Site Status RECRUITING

Research Site

Créteil, , France

Site Status RECRUITING

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Lyon, , France

Site Status RECRUITING

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Paris, , France

Site Status RECRUITING

Research Site

Paris, , France

Site Status RECRUITING

Research Site

Saint-Ouen, , France

Site Status RECRUITING

Countries

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United States France

Central Contacts

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Maze Therapeutics

Role: CONTACT

Phone: 650-850-5075

Email: [email protected]

Other Identifiers

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MZE829-201

Identifier Type: -

Identifier Source: org_study_id