Clinical trial NCT06830629: A Phase 2 Study of MZE829 in Adults with APOL1 Kidney Disease
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Proteinuric Kidney Disease
Keywords: APOL1-mediated kidney disease (AMKD)
APOL1 kidney disease (AKD)
Lead sponsor: Maze Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety and tolerability as assessed by incidence of adverse events (AEs)
timeFrame: Day 1 to Week 12
Secondary outcomes:
measure: Percent participants with ≥30% reduction from baseline in UACR at Week 12
timeFrame: Day 1 to Week 12
measure: Geometric mean plasma drug concentrations
timeFrame: Day 1 to Week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Apogee Clinical Research
state: Alabama
city: Fairfield
country: United States
facility: Amicis Research Center
state: California
city: Granada Hills
country: United States
facility: Amicis Research Center
state: California
city: Palmdale
country: United States
facility: Amicis Research Center
state: California
city: Valencia
country: United States
facility: Amicis Research Center
state: California
city: Brandon
country: United States
facility: Clinical Research of Brandon, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Florida Kidney Physicians
state: Florida
city: Jacksonville
country: United States
facility: Florida Kidney Physicians
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Riverview
country: United States
facility: Florida Kidney Physicians
state: Florida
city: College Park
country: United States
facility: Primeway Clinical Research Group
state: Georgia
city: Chicago
country: United States
facility: Research by Design, LLC
state: Illinois
city: Flint
country: United States
facility: Aa Mrc Mhs
state: Michigan
city: Shelby Township
country: United States
facility: St. Clair Nephrology Research
state: Michigan
city: Fayette
country: United States
facility: Prime Health and Wellness
state: Mississippi
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center
state: Mississippi
city: Las Vegas
country: United States
facility: AB Clinical Trials
state: Nevada
city: Greensboro
country: United States
facility: Carolina Kidney Associates, P.A.
state: North Carolina
city: Upland
country: United States
facility: Clinical Renal Associates
state: Pennsylvania
city: Spartanburg
country: United States
facility: CN Clinical Research, LLC
state: South Carolina
city: Houston
country: United States
facility: Renal Specialist
state: Texas
city: Arlington
country: United States
facility: Virginia Nephrology Group
state: Virginia
Study officials:
affiliation: Maze Therapeutics
name: Medical Director
role: STUDY_DIRECTOR
References: