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Study of MZE829 capsules for adults with APOL1 kidney disease and protein in urine

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on APOL1 Kidney Disease (AKD), a specific type of chronic kidney disease that is linked to certain genetic variations. The investigational medication used in this study is called MZE829, which comes in the form of hard capsules that are taken by mouth.

The purpose of this research is to evaluate how safe and well-tolerated MZE829 is in adults who have kidney disease with high levels of protein in their urine (proteinuria) and carry specific high-risk genetic variations. This is a Phase 2 study, which means it follows initial safety testing of the medication in humans and aims to further understand how the treatment works in patients with the disease.

During the study, which lasts up to 84 days, participants will take MZE829 capsules. Throughout this period, various health assessments will be performed, including monitoring of side effects, vital sign measurements, laboratory tests, and heart rhythm recordings. These assessments help determine how safe the medication is and how well patients tolerate it.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical assessment

    Your eligibility for the study will be confirmed through medical tests and evaluation of your kidney function

    The medical team will verify if you meet the age requirement (18-65 years) and body mass index (18-45)

    Tests will confirm if you have the specific APOL1 genetic variant required for the study

  2. Step 2

    Kidney function verification

    Your kidney filtration rate will be measured to ensure it falls within the required range (25-90 mL/min/1.73 m²)

    The medical team will assess your urine protein levels to confirm the presence of high albumin

  3. Step 3

    Treatment administration

    You will receive MZE829 in the form of hard capsules for oral use

    The medication will be taken by mouth according to the prescribed schedule

  4. Step 4

    Ongoing monitoring

    Regular health checks will include vital signs measurements

    Blood tests will be performed to monitor your kidney function

    Heart monitoring through ECG (heart rhythm recording) will be conducted

    Any side effects or health changes will be recorded

  5. Step 5

    Study duration

    The study is scheduled to run from May 2025 to September 2026

    Your participation duration will be determined by the study protocol

Who can join the trial?

5 criteria

  • Age must be between 18 and 65 years old when signing the consent form
  • Body Mass Index (BMI) must be between 18 and 45 kg/m² and total body weight must be at least 40 kg (BMI is a measure of body fat based on height and weight)
  • Must have confirmed APOL1 high risk genotype of either G1/G1, G2/G2, or G1/G2 (specific genetic variations related to kidney disease)
  • Must have diagnosed chronic kidney disease with persistent high levels of protein in urine
  • Must have kidney function (measured as estimated glomerular filtration rate or eGFR) between 25 and less than 90 mL/min/1.73 m² during screening (eGFR measures how well your kidneys filter waste from your blood)

Who cannot join the trial?

15 criteria

  • History of kidney transplant or currently on dialysis treatment
  • Presence of other types of kidney diseases not related to APOL1 gene mutations
  • Severe uncontrolled high blood pressure (blood pressure readings consistently above 160/100 mmHg)
  • Current pregnancy or breastfeeding
  • History of severe allergic reactions to medications
  • Active or chronic infections, including but not limited to HIV, hepatitis B, or hepatitis C
  • Significant heart problems or history of heart attack in the past 6 months
  • Active cancer or cancer treatment within the past 5 years
  • Severe liver disease or abnormal liver function tests
  • Participation in another clinical trial within the past 30 days
  • Use of medications that could interact with the study drug
  • Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m² (a measure of kidney function)
  • History of substance abuse within the past year
  • Mental health conditions that could interfere with study participation
  • Unable to provide informed consent or follow study procedures
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Investigated drugs

MZE829 is an investigational medication being studied for treating kidney disease, specifically in patients who have a high-risk genetic variant of the APOL1 gene. This medication is being tested to see if it can help reduce the amount of protein in the urine (albuminuria) of patients with chronic kidney disease. It's a new treatment approach that targets specific genetic factors involved in kidney damage.

What is already known about the treatment

MZE829 - An investigational medication being studied for the treatment of APOL1 Kidney Disease (AKD), a specific type of proteinuric chronic kidney disease associated with genetic variants in the APOL1 gene. The drug is currently undergoing Phase 2 clinical trials to evaluate its safety, tolerability, and effectiveness in reducing albuminuria (protein in urine) in adult patients with the APOL1 high-risk genotype. While the exact mechanism of action and form of administration are not publicly disclosed in the current clinical trial data, this experimental therapy represents a targeted approach to treating this genetic form of kidney disease. The medication is being developed specifically for patients who have both proteinuria and confirmed APOL1 genetic risk factors.

Investigated diseases

APOL1 Kidney Disease (AKD) - A genetic kidney disorder caused by mutations in the APOL1 gene that primarily affects people of African ancestry. The disease causes damage to the kidneys' filtering units, leading to protein leakage into urine (proteinuria). It is characterized by progressive loss of kidney function over time. The condition can cause swelling in various parts of the body and changes in urination patterns. The disease progression varies among individuals, with some experiencing faster decline in kidney function than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517525-10-00Protocol codeMZE829-201Estimated enrolment86 patientsSponsorMaze Therapeutics Inc.

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