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MZE829

A Phase 2 clinical trial is currently investigating MZE829, a promising new drug for adults with APOL1 Kidney Disease. This open-label study aims to evaluate how safe and effective MZE829 is for patients with proteinuric chronic kidney disease who have the APOL1 high-risk genotype. The trial is examining the drug’s impact on albuminuria (protein in urine), a key indicator of kidney function, in two groups of patients: those with chronic kidney disease with concurrent diabetes and those without diabetes. MZE829 is administered as oral capsules, making it a potentially convenient treatment option if proven effective.

Table of Contents

What is MZE829?

MZE829 is an investigational medication currently being studied for the treatment of kidney disease associated with the APOL1 gene. It is administered as oral capsules and represents a potential breakthrough for patients with specific genetic kidney conditions[1]. The drug is currently undergoing Phase 2 clinical trials to evaluate its safety and effectiveness.

What is APOL1 Kidney Disease?

APOL1 kidney disease is a condition that affects people who have certain high-risk variations of the APOL1 gene. This genetic kidney disease is characterized by proteinuria (protein in the urine), which indicates kidney damage. When proteins such as albumin leak into the urine (albuminuria), it’s a sign that the kidneys’ filtering function is compromised[1].

This condition can progress to chronic kidney disease (CKD), which means long-term kidney damage that can get worse over time. People with the APOL1 high-risk genetic variants are more susceptible to developing this type of kidney disease and may experience faster progression to kidney failure compared to those without these genetic variants[1].

Current Clinical Trial of MZE829

MZE829 is currently being studied in an open-label Phase 2 clinical trial. “Open-label” means that both the researchers and participants know which treatment is being administered. The primary purpose of this study is to evaluate the safety, tolerability, and effect of MZE829 on reducing albuminuria in adults with APOL1 kidney disease[1].

The trial focuses on participants who have both proteinuric chronic kidney disease (kidney disease with protein in the urine) and the APOL1 high-risk genotype (specific genetic variants that increase kidney disease risk)[1].

How MZE829 Works

While the exact mechanism of action isn’t fully detailed in the available information, MZE829 is designed to target the underlying problems associated with APOL1 kidney disease. The drug aims to reduce albuminuria, which is the presence of albumin protein in the urine and a key indicator of kidney damage[1].

By potentially reducing albuminuria, MZE829 may help slow the progression of kidney damage and preserve kidney function in people with the APOL1 high-risk genotype[1].

Who Can Benefit from MZE829?

The clinical trial for MZE829 includes two specific groups of participants[1]:

  • Cohort 1: People with chronic kidney disease who also have diabetes. Diabetes is a common cause of kidney disease, and these patients may have additional complications related to their diabetes[1].
  • Cohort 2: People with chronic kidney disease who do not have diabetes. This helps researchers understand how the medication works in kidney disease that isn’t complicated by diabetes[1].

All participants must have the APOL1 high-risk genotype and proteinuric kidney disease to be eligible for the study[1].

Expected Outcomes of MZE829 Treatment

The clinical trial is measuring several important outcomes to determine if MZE829 is effective and safe[1]:

  1. Primary outcome: Safety and tolerability, assessed by monitoring for any side effects or adverse events from the start of treatment until week 12[1].
  2. Secondary outcomes:
    • The percentage of participants who achieve at least a 30% reduction in UACR (Urinary Albumin-to-Creatinine Ratio) by week 12. UACR is a test that measures the amount of albumin in your urine compared to creatinine, providing an indication of kidney function[1].
    • The geometric mean plasma drug concentrations, which shows how much of the drug is present in the bloodstream over time. This helps researchers understand how the body processes the medication[1].

The trial will follow participants for 12 weeks to assess these outcomes[1].

How MZE829 is Administered

MZE829 is provided as capsules for oral administration, which means participants can take the medication by mouth[1]. This makes it relatively convenient compared to other treatments that might require injections or infusions. The specific dosing schedule and instructions would be provided to participants in the clinical trial.

Study Aspect Details
Study Type Phase 2, Open-Label Clinical Trial
Drug Name MZE829
Administration Oral capsules
Target Condition APOL1 Kidney Disease (Proteinuric Chronic Kidney Disease with APOL1 High Risk Genotype)
Study Participants Adults divided into two cohorts:
1. Chronic kidney disease with concurrent diabetes
2. Chronic kidney disease without concurrent diabetes
Primary Outcome Safety and tolerability assessed by incidence of adverse events (Day 1 to Week 12)
Key Secondary Outcomes 1. Percentage of participants with ≥30% reduction in UACR at Week 12
2. Geometric mean plasma drug concentrations
Study Duration 12 weeks
Clinical Trial Identifier NCT06830629

FAQ

  • What is APOL1 Kidney Disease? APOL1 Kidney Disease is a form of chronic kidney disease associated with specific genetic variants in the APOL1 gene. People with the 'high-risk genotype' have an increased risk of developing kidney problems, including proteinuria (excess protein in urine) and progressive kidney damage. This condition disproportionately affects people of African ancestry.
  • How does MZE829 work for kidney disease? Based on the clinical trial information, MZE829 is being studied specifically for patients with APOL1 Kidney Disease. While the exact mechanism isn't detailed in the trial description, the drug is being evaluated for its ability to reduce albuminuria (protein in urine), which is an important marker of kidney damage and function.
  • Who can participate in this MZE829 clinical trial? The trial is enrolling adults with proteinuric chronic kidney disease who have the APOL1 high-risk genotype. Participants are divided into two cohorts: those with chronic kidney disease with concurrent diabetes and those with chronic kidney disease without diabetes. Specific eligibility criteria regarding age, kidney function values, and other medical conditions would be determined by the study investigators.
  • How is MZE829 administered in the trial? MZE829 is administered as capsules for oral administration. This means participants take the medication by mouth. The specific dosing schedule and amount is not detailed in the trial summary, but would be carefully controlled as part of the study protocol.
  • What outcomes are researchers measuring in this trial? The primary outcome researchers are measuring is the safety and tolerability of MZE829 by tracking adverse events from Day 1 to Week 12. Secondary outcomes include the percentage of participants who achieve at least a 30% reduction in urine albumin-to-creatinine ratio (UACR) by Week 12, which indicates improvement in kidney function. They are also measuring geometric mean plasma drug concentrations to understand how the drug behaves in the body.

Ongoing Clinical Trials on MZE829

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

    Recruiting

    1 1
    Investigated drugs:
    France

Glossary

  • APOL1 High Risk Genotype: A specific genetic variation in the APOL1 gene that increases risk for kidney disease. This genotype is more common in people of African ancestry and can lead to faster progression of kidney disease.
  • Albuminuria: The presence of albumin (a protein) in the urine, which is a sign of kidney damage. Healthy kidneys typically prevent protein from passing into urine.
  • Chronic Kidney Disease (CKD): A condition characterized by gradual loss of kidney function over time. CKD can progress to kidney failure if not treated.
  • Open-Label Study: A type of clinical trial where both the researchers and participants know which treatment is being administered. This differs from blinded studies where participants don't know what treatment they're receiving.
  • Phase 2 Study: The second phase of clinical trials that tests a drug's effectiveness and further evaluates its safety in a larger group of patients with the condition being studied.
  • Proteinuria: The presence of excess proteins in the urine, which is a sign of kidney damage. Proteinuric kidney disease refers to kidney disease characterized by this symptom.
  • UACR (Urine Albumin-to-Creatinine Ratio): A test that measures the amount of albumin relative to creatinine in urine. It's used to detect early signs of kidney damage and monitor kidney function.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease that develops during a clinical trial, whether or not it's related to the treatment being studied.
  • Geometric Mean Plasma Drug Concentrations: A measurement of the amount of drug in the blood plasma, calculated using the geometric mean (a type of average) to understand how the drug is absorbed, distributed, and eliminated by the body.
  • Cohort: A group of participants in a study who share a common characteristic. In this trial, there are two cohorts: patients with kidney disease and diabetes, and patients with kidney disease without diabetes.

References