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RecruitingPHASE2INTERVENTIONAL

Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease

This study, called a Phase 2 trial, is looking at a new medicine named ADX-038. It's for adults who have specific kidney diseases where their immune system, specifically something called the complement system, isn't working quite right and is damaging their kidneys. These conditions include IgA nephropathy (IgAN) and C3 glomerulopathy (C3G). The main goals are to check if ADX-038 is safe to use, if it helps to improve these kidney conditions, and how the body handles the medicine. Doctors will be giving different doses of ADX-038 to see which works best. This is an important step in finding new treatments for these complex kidney problems.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
ADARx Pharmaceuticals, Inc.
Enrolment target
45
Start
28 Aug 2025
Estimated completion
01 Jun 2029

What is this study about?

This study is a ‘Phase 2’ clinical trial, which means researchers are carefully testing a new medicine called ADX-038 for the first time in a larger group of people, after initial safety tests. The medicine is designed to help adults who have certain kidney diseases that are linked to a part of the body's immune system called the 'complement system'. When this system doesn't work correctly, it can attack and damage the kidneys.

The specific conditions this study is focusing on include IgA nephropathy (IgAN), C3 glomerulopathy (C3G), and IC-MPGN. These diseases can lead to serious kidney problems. Researchers want to find out if ADX-038 can make a difference by protecting the kidneys and slowing down the disease progression.

The main aim of this study is to learn more about ADX-038. This includes understanding if it's safe for people to take, how well it works to treat these kidney conditions, and how the body absorbs and uses the medicine. Discovering safer and more effective treatments for these challenging kidney diseases is very important for patients.

Key takeaways

  • This study is testing a new medicine (ADX-038) for specific kidney diseases.
  • It's for adults with conditions like IgA nephropathy or C3 glomerulopathy.
  • The main goals are to check for safety and if the medicine helps kidney function.
  • Participation involves regular clinic visits, blood tests, and taking the study medicine.
  • You must meet certain health criteria to be eligible for the study.
  • You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. You would need to have certain kidney conditions such as IgA nephropathy (IgAN), C3 glomerulopathy (C3G), or IC-MPGN, and this diagnosis must have been confirmed by a kidney biopsy. Your kidney function, measured by something called eGFR, should be at a certain level, and you should be receiving standard care for your kidney disease, which might include specific blood pressure medicines if your doctor thinks they are appropriate.

There are also reasons why you might not be able to join. For example, if you've had a kidney transplant or other organ transplants, or if you're currently on dialysis. You also couldn't take part if you have certain problems with your immune system, another type of kidney disease, or a history of frequent severe infections. If you've recently had other treatments that affect the complement system, or if you have severe liver problems, you'd also not be able 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 18 years old or older?
  2. Do you have a kidney disease like IgAN, C3G, or IC-MPGN, confirmed by a kidney biopsy?
  3. Do you have suitable kidney function (eGFR of 30 or higher)?
  4. Have you not had a kidney transplant or other organ transplant?
  5. Are you willing to get necessary vaccinations?
  6. Do you not have active serious infections?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medicine, ADX-038, at one of two dose levels chosen by the study team. You would have regular visits to the clinic for health checks, blood tests, and other assessments to monitor your kidney function and how you're responding to the medicine. You would also need to be willing to get certain vaccinations to ensure your safety during the study. The total duration of your participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this means you might get access to a new medicine that isn't widely available yet, which could potentially help your kidney condition. However, there's no guarantee the medicine will work, and it might have side effects that we don't fully understand yet. Your health will be closely monitored throughout the study. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (25)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • ADARx Clinical Site
    Verified postcode
    Doral, United States· Recruiting
  • ADARx Clinical Site
    Verified postcode
    Miami, United States· Recruiting
  • ADARx Clinical Site
    Verified postcode
    Pembroke Pines, United States· Recruiting
  • ADARx Clinical Site
    Verified postcode
    Iowa City, United States· Recruiting
  • ADARx Clinical Site
    Verified postcode
    Shreveport, United States· Recruiting
  • ADARx Clinical Site
    Verified postcode
    Shelby, United States· Recruiting
  • ADARx Clinical Site
    Verified postcode
    Great Neck, United States· Recruiting
  • ADARx Clinical Site
    Verified postcode
    Columbus, United States· Recruiting
  • ADARx Clinical Site
    Verified postcode
    Dakota Dunes, United States· Recruiting
  • ADARx Clinical Site
    Verified postcode
    Dallas, United States· Recruiting
  • ADARx Clinical Site
    Verified postcode
    Houston, United States· Recruiting
  • ADARx Clinical Site
    Verified postcode
    Wollongong, Australia· Recruiting

Common questions

What is the complement system?

The complement system is a part of your body's immune defence. Sometimes, it can start attacking healthy parts of the body, like the kidneys, causing damage.

What are IgAN, C3G, and IC-MPGN?

These are different types of kidney diseases where the immune system damages the tiny filters in your kidneys, making it harder for them to work properly.

What is a 'Phase 2' study?

A Phase 2 study means the new medicine has already been found safe in a small group of people, and now researchers are testing it in a larger group to see if it works and check for side effects.

Will I know if I'm getting the active medicine?

In some studies like this, participants might not know if they are receiving the active medicine or a placebo (dummy medicine), but your study doctor will explain this in detail.

Do I need to pay to be in the study?

Generally, you do not pay to be in a clinical trial. All study-related medicines and tests are usually provided free of charge, but check with the study team about any potential travel costs or other expenses.

How to find out more

Lyle Gee

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 "Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disea…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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