Evaluating MZE829 for Kidney Disease Related to APOL1 Genotype
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
This study is testing a new treatment called MZE829 to see if it can help adults with kidney disease related to a specific genetic marker and reduce protein in their urine.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 68 Years |
| Sex | All |
| Sponsor | Maze Therapeutics Industry-sponsored |
| Locations | 81 sites (Decatur, Alabama and 80 other locations) |
| Trial ID | NCT06830629 on ClinicalTrials.gov |
What this trial studies
This Phase 2 study aims to assess the safety, tolerability, and impact of MZE829 on albuminuria in adults suffering from proteinuric chronic kidney disease associated with the APOL1 high-risk genotype. The study is open-label, meaning all participants will know they are receiving the treatment. It specifically targets individuals with chronic kidney disease who have persistent albuminuria and possess certain genetic markers. The trial will monitor participants for any adverse effects while measuring changes in kidney function.
Who should consider this trial
Good fit: Ideal candidates include adults with the APOL1 high-risk genotype and chronic kidney disease characterized by persistent albuminuria.
Not a fit: Patients with organ transplants, recent cancer history, or certain other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce albuminuria and improve kidney function in patients with APOL1-mediated kidney disease.
How similar studies have performed: While this approach is novel, similar studies targeting genetic factors in kidney disease have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Decatur, Alabama and 80 other locations
- Research Site — Decatur, Alabama, United States (Recruiting)
- Research Site — Huntsville, Alabama, United States (Recruiting)
- Research Site — Montgomery, Alabama, United States (Recruiting)
- Research Site — Montgomery, Alabama, United States (Recruiting)
- Research Site — Granada Hills, California, United States (Recruiting)
- Research Site — Bloomfield, Connecticut, United States (Recruiting)
- Research Site — Atlantis, Florida, United States (Recruiting)
- Research Site — Brandon, Florida, United States (Recruiting)
- Research Site — Brooksville, Florida, United States (Recruiting)
- Research Site — Hollywood, Florida, United States (Recruiting)
- Research Site — Melbourne, Florida, United States (Recruiting)
- Research Site — Miami Lakes, Florida, United States (Recruiting)
- Research Site — Orlando, Florida, United States (Recruiting)
- Research Site — Atlanta, Georgia, United States (Recruiting)
- Research Site — College Park, Georgia, United States (Recruiting)
- Research Site — Cordele, Georgia, United States (Recruiting)
- Research Site — Lithia Springs, Georgia, United States (Recruiting)
- Research Site — Macon, Georgia, United States (Recruiting)
- Research Site — Riverdale, Georgia, United States (Recruiting)
- Research Site — Riverdale, Georgia, United States (Recruiting)
- Research Site — Savannah, Georgia, United States (Recruiting)
- Research Site — Snellville, Georgia, United States (Recruiting)
- Research Site — Chicago, Illinois, United States (Recruiting)
- Research Site — Chicago, Illinois, United States (Recruiting)
- Research Site — Kansas City, Kansas, United States (Recruiting)
- Research Site — Bowling Green, Kentucky, United States (Recruiting)
- Research Site — Louisville, Kentucky, United States (Recruiting)
- Research Site — Arnold, Maryland, United States (Recruiting)
- Research Site — Lutherville, Maryland, United States (Recruiting)
- Research Site — Oxon Hill, Maryland, United States (Recruiting)
- Research Site — Dearborn, Michigan, United States (Recruiting)
- Research Site — Flint, Michigan, United States (Recruiting)
- Research Site — Pontiac, Michigan, United States (Recruiting)
- Research Site — Saint Joseph, Michigan, United States (Recruiting)
- Research Site — Shelby, Michigan, United States (Recruiting)
- Research Site — Minneapolis, Minnesota, United States (Recruiting)
- Research Site — Tupelo, Mississippi, United States (Recruiting)
- Research Site — City of Saint Peters, Missouri, United States (Recruiting)
- Research Site — St Louis, Missouri, United States (Recruiting)
- Research Site — Las Vegas, Nevada, United States (Recruiting)
- Research Site — Buffalo, New York, United States (Recruiting)
- Research Site — Laurelton, New York, United States (Recruiting)
- Research Site — Maspeth, New York, United States (Recruiting)
- Research Site — New York, New York, United States (Recruiting)
- Research Site — Newburgh, New York, United States (Recruiting)
- Research Site — Durham, North Carolina, United States (Recruiting)
- Research Site — Fayetteville, North Carolina, United States (Recruiting)
- Research Site — Greensboro, North Carolina, United States (Recruiting)
- Research Site — Shelby, North Carolina, United States (Recruiting)
- Research Site — Cincinnati, Ohio, United States (Recruiting)
+31 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Maze Therapeutics
- Email: APOL1info@mazetx.com
- Phone: 650-850-5075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.