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 is purpose of this study is to evaluate the safety, tolerability, and effect on Albuminuria of MZE829 in Adults with APOL1 Kidney Disease To explore kidney disease biomarkers in patients with proteinuric kidney disease.

CT.gov Identifier
NCT06830629
EudraCT Identifier
N/A
CTIS:
2024-517525-10-00
Sponsor
Maze Therapeutics
Collaborator
N/A
Study Contact Information
+1 650 850 5070
Recruiting
Contact Us

Study Details

Diseases
APOL1 Mediated Kidney Disease (AMKD)
Focal Segmental Glomerulosclerosis
Study Drug
MZE-829
Genes
APOL1
Study Dates
Feb 2025 - Sep 2026
Sex
Female & Male
Age
18 - 84 Years
Inclusion and Exclusion Criteria
Inclusion Criteria:
  • Key
  • * APOL1 high risk genotype of G1/G1, G2/G2, or G1/G2
  • * Chronic kidney disease with persistent albuminuria
  • All Cohorts
  • Inclusion:
  • CKD diagnosis with uACR ≥ 300mg/g (except Cohort 3) • eGFR ≥25 mL/min/1.73m2 to <90 mL/min/1.73m2 • Stable SOC treatment ≥8 weeks prior to screening
  • Cohort 1:
  • Inclusion:
  • Diabetic • Concurrent diagnosis of type 2 diabetes • Inclusive of HTN-related CKD and FSGS
  • Cohort 2:
  • Inclusion:
  • Nondiabetic • Diagnosis of CKD attributed to hypertension or FSGS with or without biopsy •Without a known cause for CKD other than APOL1
  • Cohort 3:
  • Inclusion:
  • Severe FSGS • Biopsy-confirmed FSGS with uPCR ≥ 1500mg/g
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.
  • All Cohorts
  • Potent immunosuppressants ≤12 weeks prior to screening cyclosporine, tacrolimus, CellCept permitted Systemic corticosteroids ≤8 weeks prior to screening Kidney disease attributed to other known causes Sickle trait permitted Solitary native kidney permitted For participants with kidney biopsy: ≥50% fibrosis
  • Cohort 1:
  • HgbA1c >8% or brittle diabetes Type I diabetes
  • Cohort 2:
  • Type I or II diabetes
  • Cohort 3:
  • Type I or II diabetes

Protocol 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

To explore kidney disease biomarkers in patients with proteinuric kidney disease.

Study Locations

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