Proteinuric Kidney Disease
Conditions
Keywords
APOL1-mediated kidney disease (AMKD), APOL1 kidney disease (AKD)
Brief summary
The 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.
Interventions
DRUGMZE829
Capsules for oral administration
Sponsors
Maze Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
No
Inclusion 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 active cancer within past 2 years, except 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability as assessed by incidence of adverse events (AEs) | Baseline to Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percent participants with ≥30% reduction from baseline in UACR at Week 12 | Baseline to Week 12 |
| Geometric mean plasma drug concentrations | Baseline to Week 12 |
Countries
France, United Kingdom, United States
Contacts
CONTACTMaze Therapeutics
STUDY_DIRECTORMedical Director
Maze Therapeutics
Outcome results
None listed