A Phase 2 Study of MZE829 in Adults with APOL1 Kidney Disease
- Registration Number
- NCT06830629
- Lead Sponsor
- Maze Therapeutics
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 56
- APOL1 high risk genotype of G1/G1, G2/G2, or G1/G2
- Chronic kidney disease with persistent albuminuria
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MZE829 MZE829 Cohort 1: Chronic kidney disease with concurrent diabetes Cohort 2: Chronic kidney disease without concurrent diabetes
- Primary Outcome Measures
Name Time Method Safety and tolerability as assessed by incidence of adverse events (AEs) Day 1 to Week 12
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
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Trial Locations
- Locations (17)
Apogee Clinical Research
🇺🇸Huntsville, Alabama, United States
Amicis Research Center
🇺🇸Valencia, California, United States
Clinical Research of Brandon, LLC
🇺🇸Brandon, Florida, United States
Florida Kidney Physicians
🇺🇸Riverview, Florida, United States
San Marcus Research Clinic, Inc.
🇺🇸Miami Lakes, Florida, United States
Primeway Clinical Research Group
🇺🇸College Park, Georgia, United States
Research by Design, LLC
🇺🇸Chicago, Illinois, United States
Aa Mrc Mhs
🇺🇸Flint, Michigan, United States
St. Clair Nephrology Research
🇺🇸Shelby Township, Michigan, United States
Prime Health and Wellness
🇺🇸Fayette, Mississippi, United States
SKY Integrative Medical Center
🇺🇸Ridgeland, Mississippi, United States
AB Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Carolina Kidney Associates, P.A.
🇺🇸Greensboro, North Carolina, United States
Clinical Renal Associates
🇺🇸Upland, Pennsylvania, United States
CN Clinical Research, LLC
🇺🇸Spartanburg, South Carolina, United States
Renal Specialist
🇺🇸Houston, Texas, United States
Virginia Nephrology Group
🇺🇸Arlington, Virginia, United States