A Phase 2 Study of MZE829 in Adults with APOL1 Kidney Disease
Research type
Research Study
Full title
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
IRAS ID
1011607
Contact name
Emilia Gajda
Contact email
Sponsor organisation
Maze Therapeutics Inc.
Eudract number
2024-517525-10
Clinicaltrials.gov Identifier
Research summary
This is a phase 2 study to evaluate the safety of MZE829 in adults with chronic kidney disease (CKD) and a high-risk APOL1 gene, and to study the effects of MZE829 on the amount of protein in your urine.
CKD is a long-term condition where the kidneys do not work as well as they should.
The APOL1 gene makes the APOL1 protein that is involved in body’s immune system. People who have the high-risk form of APOL1, which is most commonly found in people of African ancestry, are more likely to have kidney disease and experience more severe forms of it. By blocking APOL1 protein, MZE829 may help decrease damage to the kidneys.
The main purpose of this research study is to evaluate the safety of MZE829 in adults with CKD and a high-risk APOL1 gene, and to study the effects of MZE829 on the amount of protein in participants urine. Albuminuria is when a protein called albumin ends up in the urine. If there's too much of this protein, it might mean there’s an issue with the kidneys.
This research study will take place at approximately 100 sites globally with about 68 people with CKD and a high-risk APOL1 gene participating.
Participants will be in this research study for approximately 22 weeks, and they will need to come to the study sites at least 8 times over this period (unless they opt for home health visits).
This study is divided into 3 periods: a screening period, a treatment period, and a follow-up period. During each study period, participants will have 1 or more visits with their study doctor at the site or at home. The screening visit(s) and Day 1 visit will last a total of 5 hours each, and all other visits will last a total of 3 hours.REC name
East of Scotland Research Ethics Service REC 2
REC reference
25/ES/0026
Date of REC Opinion
21 May 2025
REC opinion
Further Information Favourable Opinion