Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
RecruitingRare disease
A study to evaluate the effect of zigakibart in adults with IgA nephropathy
Fast replyInvestigational
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study investigates the effects of zigakibart in adults diagnosed with IgA nephropathy. IgA nephropathy is a rare kidney disease where an antibody called immunoglobulin A builds up in the kidneys, causing inflammation and damage to the organ's filtering units. The purpose of the study is to determine if treatment with zigakibart can change the course of this disease. The medication will be administered via subcutaneous injection, which is a shot given into the fatty tissue just under the skin.
During the study, participants will receive the medication over a period of up to two years. Researchers will monitor how the treatment affects various markers of kidney health. This includes looking at kidney tissue through a biopsy, which is a procedure to remove a small piece of the organ for examination, to check for changes in inflammation and the severity of the disease. Additionally, blood and urine tests will be used to track kidney function, such as the estimated glomerular filtration rate, which is a measure of how well the kidneys filter waste from the blood, and the amount of protein present in the urine.
Other aspects of the study involve monitoring how the medication affects the body's immune system, including the response to vaccines and the levels of different immunoglobulins, which are proteins that help the immune system fight infections. The concentration of the drug in the blood and the presence of any antibodies created by the body against the medication will also be tracked. This allows for a comprehensive look at how zigakibart influences both the disease process and the body's overall response to the treatment.
The research process
The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
8 criteria
- You must be an adult, meaning you are 18 years of age or older.
- You must weigh at least 45 kg (approximately 99 pounds).
- Your Body Mass Index (BMI), which is a measure of your body weight relative to your height, must not be greater than 35.0.
- You must have been diagnosed with IgA nephropathy, a kidney disease, within the last 5 years.
- You must have moderate kidney function, which is measured by an eGFR (estimated Glomerular Filtration Rate, a test that shows how well your kidneys filter waste) of 45 or higher.
- You must show signs of persistent protein in the urine, which means protein is continuously leaking into your urine despite taking standard supportive treatments.
- This protein level is measured as either a total of 0.5 grams or more of protein per day or a urine protein-creatinine ratio (UPCR)—a calculation used to estimate how much protein is lost in the urine—of 0.5 or higher.
- If you were diagnosed within the last 6 months, the protein levels must be higher, specifically more than 1.5 grams of protein per day or a UPCR of more than 1.5.
Who cannot join the trial?
6 criteria
- You do not have IgA vasculitis, which is a condition that causes inflammation in the small blood vessels.
- You do not have a weakened immune system, which is when your body's natural defense system against germs is not working well.
- Your immunoglobulin levels, which are proteins in your blood that help fight infections, are not low (specifically, your Total IgG must be at least 6.0 g/L).
- You do not have urinary problems, such as having infections in the urinary tract frequently or having difficulty emptying your bladder.
- You do not have high blood pressure (also known as hypertension) that is not being managed effectively with medicine.
- You have not used immunosuppressant medications, which are drugs that lower your body's ability to fight infection, in the last year (this does not include the short-term use of corticosteroids, which are a type of steroid medicine used to reduce inflammation).
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Verified sites
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Verified Responsive Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Lodz, PolandResponsive Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland
Trial locations
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Investigated drugs
Zigakibart is an investigational medicine given as a shot under the skin. It is being studied to see if it can help change the course of kidney disease in adults by affecting certain markers in the body related to kidney function and damage.
What is already known about the treatment
Zigakibart - This medication is an experimental treatment administered as a solution through a simple injection under the skin. It is currently being studied in clinical trials and is not yet widely available for general medical use. The drug is designed to treat IgA nephropathy, a rare kidney disease, by targeting and blocking specific proteins in the immune system that cause inflammation and damage to the kidneys. It is classified as a targeted biological therapy that works at the molecular level to stop the body's immune response from attacking its own kidney tissue.
Investigated diseases
IgA nephropathy - This is a condition where an antibody called immunoglobulin A builds up in the kidneys. This buildup causes inflammation within the kidney's filtering units. Over time, the inflammation can lead to damage to the kidney tissues. This process may result in the presence of protein in the urine. As the disease progresses, the kidneys may lose their ability to filter waste from the blood effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519699-24-00Protocol codeCFUB523A12201Estimated enrolment32 patientsSponsorNovartis Pharma AG
sourced from the EU Clinical Trials Register and site verification
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