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RecruitingPHASE2INTERVENTIONAL

A Phase 2 Study of MZE829 in Adults With APOL1 Kidney Disease

This research study is investigating a new medication called MZE829 for adults who have a specific inherited kidney condition known as APOL1-mediated kidney disease. This condition can lead to too much protein in the urine, which is a sign of kidney damage. The main goals of this study are to evaluate the safety of MZE829, how well people tolerate the medication, and whether it can help reduce the amount of protein leaking into the urine. This is a Phase 2 study, meaning the treatment has already undergone initial safety checks and is now being looked at in more detail to see its effects. The findings could help us understand if MZE829 is a promising new treatment option for this type of kidney disease.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Maze Therapeutics
Enrolment target
56
Start
05 Feb 2025
Estimated completion
01 Sep 2026

What is this study about?

This study is a Phase 2 clinical trial exploring a new medication, MZE829, for adults with a specific type of kidney disease. This particular condition is linked to changes in a gene called APOL1. If you have these changes, your kidneys might not work as well as they should, leading to problems like too much protein in your urine (this is called albuminuria or proteinuric kidney disease).

The main aim of this study is to find out if MZE829 is safe to use and if people can take it without too many side effects. We also want to see if this medication can help reduce the amount of protein in the urine. Reducing protein in the urine is important because it can be a sign that kidney damage is progressing. If MZE829 proves to be helpful, it could potentially slow down kidney disease in people with the APOL1 gene changes.

Understanding how safe and effective this potential new treatment is for people with APOL1-mediated kidney disease is very important. The results from this study will help researchers decide if MZE829 should be studied further in a larger group of people, with the eventual hope of providing a new treatment option for this condition.

Key takeaways

  • This study is testing a new medicine, MZE829, for a specific type of kidney disease.
  • It aims to check the safety, tolerability, and effect on protein in the urine.
  • Participants must have APOL1 high-risk genes and chronic kidney disease with protein in their urine.
  • The study is for adults aged 18 to 68.
  • Regular clinic visits, blood, and urine tests will be part of participation.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be between 18 and 68 years old and have been diagnosed with chronic kidney disease where you have persistent protein in your urine. You would also need to have specific changes in your APOL1 gene (known as the high-risk gene type) that are linked to this kind of kidney disease.

However, there are some reasons why you might not be able to participate. For example, if you've had an organ or bone marrow transplant, or if you've been treated for cancer in the last two years (with some exceptions like certain skin or early-stage cervical/prostate cancers). We also couldn't include you if you have Type 1 diabetes, or if you're pregnant or breastfeeding.

Additionally, conditions that might affect how your body absorbs medication, such as certain types of stomach surgery, would prevent you from taking part. The study team will review all specific medical history to ensure it's safe and appropriate for you to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 68 years old?
  2. Do you have chronic kidney disease with protein in your urine?
  3. Have you been told you have the high-risk APOL1 gene changes?
  4. Have you NOT had an organ or bone marrow transplant?
  5. Are you NOT pregnant or currently breastfeeding?
  6. Do you NOT have Type 1 diabetes?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study medication, MZE829. You will have regular visits to the clinic, where the study team will monitor your health closely. These visits will involve blood tests, urine tests, and other checks to see how your kidneys are doing and how you are responding to the medication. The team will also ask about any side effects you might be experiencing. We will explain how often these visits are, but generally research studies involve more frequent check-ups than routine care. The total duration of your participation in the study, including all visits and follow-ups, will be clearly explained to you before you make any decisions.

Potential risks and benefits

Participating in a clinical trial has both potential benefits and risks. You might benefit from receiving a new medication for your kidney disease that isn't widely available yet, which could potentially help manage your condition. However, there's also a chance MZE829 might not work for you, or it could cause side effects. The study team will closely monitor your health for any side effects and will explain all known risks before you agree to participate. Remember, taking part is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (81)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Decatur, United States· Recruiting
  • Research Site
    Verified postcode
    Huntsville, United States· Recruiting
  • Research Site
    Verified postcode
    Montgomery, United States· Recruiting
  • Research Site
    Verified postcode
    Montgomery, United States· Recruiting
  • Research Site
    Verified postcode
    Granada Hills, United States· Recruiting
  • Research Site
    Verified postcode
    Bloomfield, United States· Recruiting
  • Research Site
    Verified postcode
    Atlantis, United States· Recruiting
  • Research Site
    Verified postcode
    Brandon, United States· Recruiting
  • Research Site
    Verified postcode
    Brooksville, United States· Recruiting
  • Research Site
    Verified postcode
    Hollywood, United States· Recruiting
  • Research Site
    Verified postcode
    Melbourne, United States· Recruiting
  • Research Site
    Verified postcode
    Miami Lakes, United States· Recruiting

Common questions

What is APOL1 kidney disease?

It's a type of kidney disease linked to specific changes in a gene called APOL1, which can cause kidney damage and protein in the urine.

What does 'proteinuric kidney disease' mean?

It means you have an unhealthy amount of protein leaking into your urine, which can be a sign that your kidneys aren't working as they should.

Is MZE829 a new type of medicine?

Yes, MZE829 is a new investigational medication that is being tested in this study to see if it can help people with APOL1 kidney disease.

What is a Phase 2 study?

A Phase 2 study means the medicine has already passed initial safety checks and is now being studied in more detail to see its effects and safety in a specific group of patients.

Can I still participate if I have Type 1 diabetes?

No, unfortunately, having Type 1 diabetes is one of the reasons that would prevent you from being able to join this particular study.

How to find out more

Maze Therapeutics

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Phase 2 Study of MZE829 in Adults With APOL1 Kidney Diseas…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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