Proteinuric Kidney DiseasePhase 2NCT06830629
A Phase 2 Study of MZE829 in Adults With APOL1 Kidney Disease
A Phase 2 study testing MZE829 in people with Proteinuric Kidney Disease, run by Maze Therapeutics at 79 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and effect on Albuminuria of MZE829 in Adults with APOL1 Kidney Disease. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Proteinuric Kidney Disease
- What is being tested?
- MZE829
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 79 sitesin 3 countries
- Study dates
- 5 Feb 2025to Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- APOL1 high risk genotype of G1/G1, G2/G2, or G1/G2
- Chronic kidney disease with persistent albuminuria
Who cannot join
- 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/exclusion criteria defined in protocol apply.
Trial locations and contacts
79 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
79 sites in 3 countries
United States68 sites, 68 recruiting
- Recruiting
Research Site
Ardmore, Oklahoma, 73401
- Recruiting
Research Site
Arnold, Maryland, 21012
- Recruiting
Research Site
Atlanta, Georgia, 30309
- Recruiting
Research Site
Atlantis, Florida, 33462
- Recruiting
Research Site
Bloomfield, Connecticut, 06112
- Recruiting
Research Site
Bowling Green, Kentucky, 42101
- Recruiting
Research Site
Brandon, Florida, 33511
- Recruiting
Research Site
Buffalo, New York, 14203
- Recruiting
Research Site
Chattanooga, Tennessee, 37404
- Recruiting
Research Site
Chicago, Illinois, 60616
- Recruiting
Research Site
Chicago, Illinois, 60643
- Recruiting
Research Site
City of Saint Peters, Missouri, 63376
- Recruiting
Research Site
Cleveland, Ohio, 44106
- Recruiting
Research Site
Cleveland, Ohio, 44195
- Recruiting
Research Site
College Park, Georgia, 30349
- Recruiting
Research Site
Columbia, South Carolina, 29203
- Recruiting
Research Site
Columbus, Ohio, 43215
- Recruiting
Research Site
Cordele, Georgia, 31015
- Recruiting
Research Site
Dallas, Texas, 75230
- Recruiting
Research Site
Dallas, Texas, 75246
- Recruiting
Research Site
Dearborn, Michigan, 48126
- Recruiting
Research Site
Decatur, Alabama, 35601
- Recruiting
Research Site
Durham, North Carolina, 27708
- Recruiting
Research Site
Evanston, Illinois, 60201
- Recruiting
Research Site
Fayetteville, North Carolina, 28304
- Recruiting
Research Site
Flint, Michigan, 48503
- Recruiting
Research Site
Greensboro, North Carolina, 27405
- Recruiting
Research Site
Greenville, Texas, 75402
- Recruiting
Research Site
Hollywood, Florida, 33024
- Recruiting
Research Site
Houston, Texas, 77030
- Recruiting
Research Site
Houston, Texas, 77054
- Recruiting
Research Site
Houston, Texas, 77099
- Recruiting
Research Site
Huntsville, Alabama, 35805
- Recruiting
Research Site
Jersey City, New Jersey, 07305
- Recruiting
Research Site
Kansas City, Kansas, 66112
- Recruiting
Research Site
Las Vegas, Nevada, 89107
- Recruiting
Research Site
Laurelton, New York, 11413
- Recruiting
Research Site
Louisville, Kentucky, 40205
- Recruiting
Research Site
Lutherville, Maryland, 21093
- Recruiting
Research Site
Macon, Georgia, 31210
- Recruiting
Research Site
Maspeth, New York, 11378
- Recruiting
Research Site
McKinney, Texas, 75069
- Recruiting
Research Site
Melbourne, Florida, 32901
- Recruiting
Research Site
Minneapolis, Minnesota, 55404
- Recruiting
Research Site
Montgomery, Alabama, 36106
- Recruiting
Research Site
Montgomery, Alabama, 36117
- Recruiting
Research Site
Newburgh, New York, 12550
- Recruiting
Research Site
Norfolk, Virginia, 23504
- Recruiting
Research Site
Orlando, Florida, 32822
- Recruiting
Research Site
Oxon Hill, Maryland, 20745
- Recruiting
Research Site
Philadelphia, Pennsylvania, 19104
- Recruiting
Research Site
Philadelphia, Pennsylvania, 19107
- Recruiting
Research Site
Pontiac, Michigan, 48341
- Recruiting
Research Site
Riverdale, Georgia, 30274
- Recruiting
Research Site
Riverdale, Georgia, 30296
- Recruiting
Research Site
Saint Joseph, Michigan, 49085
- Recruiting
Research Site
San Antonio, Texas, 78251
- Recruiting
Research Site
Savannah, Georgia, 31406
- Recruiting
Research Site
Shelby, North Carolina, 28150
- Recruiting
Research Site
Shenandoah, Texas, 77384
- Recruiting
Research Site
Sherman, Texas, 75092
- Recruiting
Research Site
Snellville, Georgia, 30078
- Recruiting
Research Site
Spartanburg, South Carolina, 29302
- Recruiting
Research Site
Spartanburg, South Carolina, 29306
- Recruiting
Research Site
St Louis, Missouri, 63103
- Recruiting
Research Site
Tupelo, Mississippi, 38801
- Recruiting
Research Site
Upland, Pennsylvania, 19013
- Recruiting
Research Site
Washington D.C., District of Columbia, 20060
France7 sites, 7 recruiting
- Recruiting
Research Site
Créteil, 94010
- Recruiting
Research Site
Lille, 59037
- Recruiting
Research Site
Lyon, 69347
- Recruiting
Research Site
Paris, 75015
- Recruiting
Research Site
Paris, 75018
- Recruiting
Research Site
Paris, 75020
- Recruiting
Research Site
Saint-Ouen, 93400
United Kingdom4 sites, 4 recruiting
- Recruiting
Research Site
Leicester, LE5 4PW
- Recruiting
Research Site
London, NW3 2QG
- Recruiting
Research Site
London, SE19RT
- Recruiting
Research Site
London, SE59RS
About this study
Official 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
The purpose of this study is to evaluate the safety, tolerability, and effect on Albuminuria of MZE829 in Adults with APOL1 Kidney Disease.
Read the 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.
- Conditions
- Proteinuric Kidney Disease
- Being tested
- MZE829
- Keywords
- APOL1-mediated kidney disease (AMKD), APOL1 kidney disease (AKD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MZE829Drug
Capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| MZE829 | Experimental | Cohort 1: Chronic kidney disease with concurrent diabetes
Cohort 2: Chronic kidney disease without concurrent diabetes Receives: Drug: MZE829 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as assessed by incidence of adverse events (AEs)
Measured: Baseline to Week 12
Secondary outcomes (2)
Percent participants with ≥30% reduction from baseline in UACR at Week 12
Measured: Baseline to Week 12
Geometric mean plasma drug concentrations
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start5 Feb 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proteinuric Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maze Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Maze Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830629
- Sponsor's protocol ID
- MZE829-201
- Status last verified
- Jul 2026
- First submitted
- 7 Feb 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06830629
- Acronym / sponsor ID
- MZE829-201
- Conditions
- Proteinuric Kidney Disease
- Keywords
- APOL1-mediated kidney disease (AMKD), APOL1 kidney disease (AKD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Maze TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MZE829 | Experimental | Drug: MZE829Cohort 1: Chronic kidney disease with concurrent diabetes Cohort 2: Chronic kidney disease without concurrent diabetes |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- APOL1 high risk genotype of G1/G1, G2/G2, or G1/G2
- Chronic kidney disease with persistent albuminuria
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MZE829Capsules for oral administration | Drug | MZE829 |
Primary outcome
Safety and tolerability as assessed by incidence of adverse events (AEs)
Time frame: Baseline to Week 12
2 secondary outcomes
Percent participants with ≥30% reduction from baseline in UACR at Week 12
Time frame: Baseline to Week 12
Geometric mean plasma drug concentrations
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Proteinuric Kidney Disease
RecruitingPhase 2
PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease
Proteinuric Kidney Diseases
Active, not recruitingPhase 2/3
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease
Proteinuric Kidney Disease
RecruitingPhase 2
Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases
Minimal Change Disease (MCD), IgA Nephropathy (IgAN)
RecruitingPhase 1
Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria
Proteinuric Renal Disease, Proteinuric Kidney Disease
Active, not recruitingPhase 2
Atrasentan in Patients With Proteinuric Glomerular Diseases
IgA Nephropathy, Focal Segmental Glomerulosclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Maze Therapeutics
79 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MZE829 in people with Proteinuric Kidney Disease, run by Maze Therapeutics at 79 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maze Therapeutics (650-850-5075, APOL1info@mazetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability as assessed by incidence of adverse events (AEs) (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.