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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Hospital Edouard Herriot	Lyon	France
Hopital Beaujon	Clichy	France
Axyl Pzunb	Saint-Ouen-sur-Seine	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.05.2025

Trial locations

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.

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 ID:

2024-517525-10-00

Protocol code:

MZE829-201

NCT ID:

NCT06830629

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?