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
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.
- Are you between 18 and 68 years old?
- Do you have chronic kidney disease with protein in your urine?
- Have you been told you have the high-risk APOL1 gene changes?
- Have you NOT had an organ or bone marrow transplant?
- Are you NOT pregnant or currently breastfeeding?
- Do you NOT have Type 1 diabetes?
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
Locations (81)
- Research SiteVerified postcodeDecatur, United States· Recruiting
- Research SiteVerified postcodeHuntsville, United States· Recruiting
- Research SiteVerified postcodeMontgomery, United States· Recruiting
- Research SiteVerified postcodeMontgomery, United States· Recruiting
- Research SiteVerified postcodeGranada Hills, United States· Recruiting
- Research SiteVerified postcodeBloomfield, United States· Recruiting
- Research SiteVerified postcodeAtlantis, United States· Recruiting
- Research SiteVerified postcodeBrandon, United States· Recruiting
- Research SiteVerified postcodeBrooksville, United States· Recruiting
- Research SiteVerified postcodeHollywood, United States· Recruiting
- Research SiteVerified postcodeMelbourne, United States· Recruiting
- Research SiteVerified postcodeMiami 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?
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