RecruitingRare disease

A study to evaluate the safety of ADX-038 in patients with complement-mediated kidney disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Complement-Mediated Kidney Disease, a rare condition where the immune system's proteins, known as the complement system, mistakenly attack the kidneys. The investigation aims to evaluate the safety and tolerability of the drug ADX-038. This medication is administered via a subcutaneous injection, which is a method of delivering medicine through a small needle just under the skin.

During the course of the study, participants will receive the study drug to monitor how the body reacts to it. Researchers will observe the effects of ADX-038 over time, specifically looking for any side effects or changes in the amount of protein released in the urine, which is often measured through a UPCR (urine protein-to-creatinine ratio) test. This test helps in understanding how well the kidneys are functioning.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study participation
Participation in this study begins with the administration of the study medication, ADX-038.
Step 2
Medication administration
The medication, ADX-038, is administered via a subcutaneous injection, which means the medicine is injected into the fatty tissue just under the skin.
The dose for the injection is 400 mg/ml (milligrams per milliliter).
Step 3
Monitoring and evaluation
Safety and how well the body tolerates the medication are monitored by tracking the frequency and severity of any treatment-emergent adverse events, which are side effects that occur during the study.
Changes in the UPCR (urine protein-to-creatinine ratio, a measurement used to check the amount of protein in the urine) are assessed using both 24-hour urine collections and spot urine samples over time.

Who can join the trial?

18 criteria

You must be at least 18 years old at the time of signing the agreement to join the study.
You must show evidence of active kidney disease, which is confirmed by a test called UPCR (a measurement of protein in the urine) showing a level of 0.8 g/g or higher from two different 24-hour urine collections.
You must have been taking supportive care, which means regular medications to manage your condition, including a stable dose of ACEi or ARB (common blood pressure medications used to protect the kidneys) for at least 30 days.
If you take diuretics (water pills used to reduce swelling or blood pressure), your other blood pressure medications must have been at a stable dose for 30 days.
If you take renoprotective medications (medicines used to protect kidney function, such as SGLT2 inhibitors or mineralocorticoid antagonists), these doses must have been stable for at least 90 days.
You must complete specific vaccination schedules for bacteria such as Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria meningitidis at least 2 weeks before starting the study.
You must agree to receive any necessary vaccine boosters (additional doses of a vaccine to maintain protection) during the study.
Women who can become pregnant must have two negative serum pregnancy tests (blood tests) during the screening process and a negative urine pregnancy test before receiving the study drug.
Women who can become pregnant must agree to use highly effective contraception (methods to prevent pregnancy) from the time they sign the consent form until 28 days after the last dose of the study drug.
You must have been offered, or been unable to take, other approved medications for your specific kidney disease.
Women who are currently breastfeeding are not eligible to participate.
Fertile men must agree to use effective contraception if they are sexually active with a partner who can become pregnant.
Fertile men must agree not to donate sperm from the start of the study until 28 days after the last dose of the study drug.
For those in the IgAN group, a diagnosis must be confirmed by a kidney biopsy (a procedure where a small piece of kidney tissue is removed for testing) performed within the last 5 years, showing less than 50% fibrosis (scarring of the kidney tissue) and less than 50% cellular crescents (a sign of severe kidney inflammation).
For those in the C3G or IC-MPGN group, a diagnosis must be confirmed by a kidney biopsy performed within the last 18 months, showing less than 50% fibrosis (scarring) and less than 50% cellular crescents (inflammation).
Participants in the C3G or IC-MPGN group who take systemic corticosteroids (steroids used to reduce inflammation throughout the body) or mycophenolic acid derivatives must have been on a stable dose for at least 3 months.
You must provide written informed consent (a signed document showing you understand and agree to participate) and follow all study rules.
Your eGFR (a calculation used to measure how well your kidneys filter waste from your blood) must be 30 mL/min/1.73m2 or higher.

Who cannot join the trial?

26 criteria

You have a known or suspected complement deficiency, which is a condition where part of your immune system that helps fight infections is not working correctly.
You have monoclonal gammopathy of uncertain significance (MGUS), which is a condition where an abnormal protein is found in the blood, or you have infections, malignancy (cancer), autoimmune diseases (conditions where the body attacks itself), or other health issues that caused your specific kidney disease.
You have a diagnosis of Henoch-Schönlein Purpura, which is also known as IgA vasculitis, an inflammation of the small blood vessels.
For certain kidney conditions, you have taken systemic corticosteroids (strong anti-inflammatory medicines that affect the whole body) within the last 3 months, unless they were used for a very short time for an urgent reason.
You have used complement inhibitor treatments (medicines that block part of the immune system) within the last 6 months or did not respond to these treatments.
You are currently using systemic immunosuppressants (drugs that lower the body's ability to fight infection) such as cyclophosphamide, JAK inhibitors, or CNI within the last 3 months, or longer-acting medicines like rituximab or obinutuzumab within the last 6 months.
You have a history of active tuberculosis (TB), an untreated latent TB infection (where the bacteria are in your body but not active), or evidence of active TB during screening.
You have had an active viral (such as COVID-19), bacterial, or fungal infection within the last 14 days.
You have a known HIV infection or tested positive for it during screening.
You have tested positive for hepatitis B or have hepatitis C with a detectable amount of the virus in your blood.
You have liver dysfunction, which means your liver is not working properly, shown by abnormal liver function tests (LFTs) like high levels of ALT, AST, or bilirubin.
Your blood pressure is too high, specifically a systolic pressure (the top number) higher than 160 mmHg or a diastolic pressure (the bottom number) higher than 90 mmHg.
You have received a kidney transplant or have needed renal replacement therapy (such as dialysis) for more than 72 hours in a row.
Your blood tests show abnormal levels, such as a white blood cell count that is too high or too low, hemoglobin (the part of red blood cells that carries oxygen) below 9 mg/dL, or a platelet count (cells that help blood clot) below 100,000/μL.
You have taken part in another interventional drug study within the last 90 days.
You have donated more than 200 mL of blood products within the last 30 days.
You have received a blood transfusion within the last 90 days.
You have previously been treated with other CFB RNA/DNA-based therapies.
You have other major medical conditions that the doctor believes might make it unsafe for you to participate or might interfere with the study results.
You have a history of a major solid organ transplant (such as the heart, lung, or liver) or a hematopoietic stem cell/bone marrow transplant.
You have other significant kidney diseases that could make it hard to understand the study's effects.
You have rapidly progressive glomerular nephritis (a fast-moving kidney inflammation) or acute kidney injury (sudden kidney damage).
You have a history of repeated invasive infections caused by encapsulated bacteria (specific types of bacteria that form a protective shell).
You have a major ongoing health problem, such as advanced cardiac disease (heart disease) or severe pulmonary disease (lung disease), or you had a major cardiovascular event (like a heart attack or stroke) in the past year.
You have active cancer or a history of cancer within the last 5 years, except for certain types of skin cancer that were completely removed.
You have a history of a splenectomy (surgical removal of the spleen).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Azienda Unita Sanitaria Locale Di Bologna
Bologna, Italy
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Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione
Pavia, Italy
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Hospital Clinico San Carlos
Madrid, Spain

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Investigated drugs

ADX-038 is an experimental medicine given as an injection under the skin. It is being studied to see if it is safe and how well patients can tolerate it while treating kidney diseases caused by the complement system.

What is already known about the treatment

ADX-038 - This medication is an experimental drug administered through a shot injected under the skin. Currently being studied in clinical trials, it is being investigated for its potential to treat rare kidney diseases caused by an overactive immune system. It works by targeting and blocking specific proteins in the body that trigger harmful inflammation in the kidneys. This substance is classified as an investigational immunotherapy designed to calm the body's defense mechanisms.

Investigated diseases

Complement-Mediated Kidney Disease - This condition occurs when certain proteins in the immune system, known as the complement system, become overactive. This overactivity leads to unintended damage to the kidneys' filtering units. As the disease progresses, the immune response continues to attack healthy kidney tissue. This can cause increased amounts of protein to leak into the urine. Over time, the damage to the kidneys may become more widespread.