A Phase 2 Study of MZE829 in Adults With APOL1 Kidney Disease

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-68
SponsorMaze Therapeutics

About this trial

The purpose of this study is to evaluate the safety, tolerability, and effect on Albuminuria of MZE829 in Adults with APOL1 Kidney Disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

APOL1 high risk genotype of G1/G1, G2/G2, or G1/G2

Chronic kidney disease with persistent albuminuria

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • MZE829

    Drug

    Capsules for oral administration

Treatment groups

74 Participants
are divided into 1 treatment group
Group A: MZE829Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability as assessed by incidence of adverse events (AEs)

Time frame
Baseline to Week 12

Secondary outcomes

1

Percent participants with ≥30% reduction from baseline in UACR at Week 12

Time frame
Baseline to Week 12
2

Geometric mean plasma drug concentrations

Time frame
Baseline to Week 12

Other outcomes

Sponsors and contacts

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