A study to evaluate the effect of zigakibart in adults with IgA nephropathy

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Istituto Di Ricerche Farmacologiche Mario Negri Ranica Italy
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Uniwersytecki Szpital Kliniczny W Opolu Opole Poland
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Universita Degli Studi Di Brescia Brescia Italy
Kjzkupxe dxy Uiwiblponatp Mspgfpkg Awf Munich Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not yet recruiting
28.03.2026
Germany Germany
Not yet recruiting
28.03.2026
Italy Italy
Recruiting
28.03.2026
Poland Poland
Not yet recruiting
28.03.2026
Spain Spain
Recruiting
28.03.2026

Trial locations

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.

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 ID:
2024-519699-24-00
Protocol code:
CFUB523A12201
NCT ID:
NCT07146906
Trial Phase:
Therapeutic exploratory (Phase II)

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