Long-Term Safety Study of Zigakibart in Adults with IgA Nephropathy Who Have Completed Previous Zigakibart Trials

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What is this study about?

This clinical trial is studying IgA nephropathy, a kidney disease in which the immune system protein called immunoglobulin A (IgA) builds up in the kidneys and can lead to damage over time. The treatment used in the study is zigakibart, also known as Bion 1301/FUB523, given as a subcutaneous injection under the skin. The purpose of the study is to find out the long-term safety and tolerability of zigakibart in adults who have already taken part in earlier zigakibart studies.

People in the study receive zigakibart during the extension period, which means treatment continues after the earlier trial has ended. The study follows participants over time to see how they do with ongoing treatment and to collect information about side effects, blood and urine test results, and other health checks. It also looks at how the body handles the medicine and whether the immune system makes proteins that react to it.

Because this is a long-term extension study, the main focus is continued treatment and follow-up rather than changing between different medicines. The study is designed to gather more safety information while participants remain on zigakibart.

Who Can Join the Study?

  • Signed informed consent must be obtained before joining the study. Informed consent means the person agrees to take part after receiving and understanding the study information.
  • The participant must have completed the parent study, meaning they finished the earlier related study, whether they had the study medicine or a placebo. A placebo is a treatment with no active medicine.
  • Based on the investigator’s medical judgment, the participant should be expected to benefit from open-label treatment with zigakibart. Open-label means everyone in the study receives the study medicine, and 600 mg s.c. Q2W means 600 milligrams given under the skin every 2 weeks.

Who Cannot Join the Study?

  • They left a previous zigakibart study early for any reason.
  • They are pregnant, breastfeeding, plan to become pregnant, or plan to donate sperm during the study and for 24 weeks after the last dose.
  • They have another serious medical or mental health problem, disease, or lab result that the study doctor thinks could make long-term treatment with zigakibart unsafe or not suitable.
  • They have a confirmed IgG level below 3 g/L before the first study treatment. IgG is a type of antibody, which is a protein that helps fight infection.
  • They are a woman who can become pregnant and are not using a highly effective form of birth control during the study and for 24 weeks after stopping treatment.
  • They are a sexually active male and are not willing to use highly effective birth control during intercourse during the study and for 24 weeks after stopping treatment.
  • They plan to donate sperm during the study or for 24 weeks after the last dose.
  • They are on chronic dialysis for at least 30 days, meaning regular machine treatment that does some of the work of the kidneys, or they need a kidney transplant.
  • They had acute kidney injury within 4 weeks before the first study treatment. Acute kidney injury means a sudden decline in kidney function.
  • They have signs or a diagnosis of rapidly progressive glomerulonephritis or another kidney filtering disease at the time of the first study treatment. This means a kidney condition that is getting worse quickly.
  • They received a live vaccine within 12 weeks before the first study treatment, or they plan to receive a live vaccine within 6 months after the last dose. A live vaccine contains a weakened germ.
  • They used systemic corticosteroids such as budesonide or other immunosuppressive medicines for more than 2 weeks during the 12 weeks before the first study treatment. Immunosuppressive medicines lower the activity of the immune system. This also includes certain listed herbs.
  • They used rituximab within 180 days before the first study treatment.
  • They have a current severe infection at the time of the first study treatment.
  • They have a history of repeated severe infections if the study doctor considers this a problem.
  • They have newly found positive tests for hepatitis A IgM antibodies, hepatitis B surface antigen, detectable hepatitis B virus DNA, hepatitis C antibodies, or HIV-1/HIV-2 antibodies. Antibodies are proteins made by the body in response to an infection.
  • They have a newly diagnosed cancer, except for certain low-risk or fully treated cancers that are allowed in the study.

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
Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Barmherzige Brueder Trier gGmbH Trier Germany
Hospital Universitario 12 De Octubre Madrid Spain
HUmani Charleroi Belgium
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
General University Hospital Of Patras Patras Greece
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Specijalna Bolnica Medico Rijeka Croatia
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Cazazmuxz Unkowluxhyvcvz Stxkwngcl Woluwe-Saint-Lambert Belgium
Uufhoypkzsxxlcyxobxni Arrctuct Augsburg Germany
Ikjyuf Bonheiden Belgium
Gqbqyre Hugndkoa Oo Tyswybiomsxo Ayfum Pntxdb Kalamaria Greece
Grrusji Htocgjwj Ow Icyydqdt Gg Hhvququevw Ioannina Greece
Hrusitom Vork dehvwugt Barcelona Spain
Ucoikefeob Gjccqzm Hrltfjjn Aokvwbk Athens Greece

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
11.08.2026
Croatia Croatia
Not yet recruiting
11.08.2026
Czechia Czechia
Not yet recruiting
11.08.2026
France France
Not yet recruiting
11.08.2026
Germany Germany
Not yet recruiting
11.08.2026
Greece Greece
Not yet recruiting
11.08.2026
Italy Italy
Not yet recruiting
11.08.2026
Spain Spain
Not yet recruiting
11.08.2026

Trial locations

Investigated drugs:

Zigakibart is the study medicine being tested in this trial. It is given as a shot under the skin. The study is checking how safe it is to use over a long period of time and how well people can tolerate it. This means the researchers want to see whether it causes any important side effects and whether participants can keep taking it without major problems. It is being studied in adults with primary IgA nephropathy, a kidney disease.

Investigated diseases:

IgA nephropathy – IgA nephropathy is a kidney disease in which a protein called IgA builds up in the kidneys and causes inflammation. Over time, this inflammation can lead to scarring and a gradual decline in kidney function. It may begin with blood or protein in the urine and can progress slowly over many years.

Trial ID:
2024-519638-22-00
Protocol code:
CFUB523A12302B
Trial Phase:
Therapeutic confirmatory (Phase III)

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