A Phase 2 Study of MZE829 in Adults With APOL1 Kidney Dis... | NCT06830629

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2025Actual

Primary Completion Date

Sep 2026Estimated

Completion Date

Sep 2026Estimated

First Submitted Date

Feb 7, 2025

First Submission Date that Met QC Criteria

Feb 12, 2025

First Posted Date

Feb 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2026

Last Update Posted Date

Apr 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MZE829	Experimental	Cohort 1: Chronic kidney disease with concurrent diabetes Cohort 2: Chronic kidney disease without concurrent diabetes	Drug: MZE829

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MZE829	Drug	Capsules for oral administration	MZE829

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability as assessed by incidence of adverse events (AEs)		Day 1 to Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percent participants with ≥30% reduction from baseline in UACR at Week 12		Day 1 to Week 12
Geometric mean plasma drug concentrations		Day 1 to Week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

68 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maze Therapeutics	Contact	650-850-5075		APOL1info@mazetx.com

Overall Officials

Name	Affiliation	Role
Medical Director	Maze Therapeutics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site	Recruiting	Decatur	Alabama	35601	United States
Research Site

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.