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ZIGAKIBART

ZIGAKIBART is being studied in clinical trials for people with IgA nephropathy, a kidney disease. These trials look at whether it can change kidney findings and how safe it is over the long term. The studies include adults who have IgA nephropathy, including people who finished earlier ZIGAKIBART trials.

Table of contents

Clinical trials overview

ZIGAKIBART is being investigated in studies for IgA nephropathy, a kidney disease that can affect how the kidneys work over time.[1][2] The trial data show two authorised interventional studies, one in Phase 2 and one in Phase 3.[1][2]

Who is being studied

The studies are focused on people with IgA nephropathy, and the brief summary for the Phase 2 trial says it asks whether ZIGAKIBART changes the course of disease in adults with IgAN.[1] The Phase 3 study includes eligible participants who have already completed previous ZIGAKIBART trials, so it follows people who already have experience with the study drug.[2]

The trial records do not provide detailed age limits, sex limits, or other entry rules beyond the population described in the source data.[1][2]

Trial phases and study design

The Phase 2 study is an interventional study, which means researchers give the study treatment and then observe what happens.[1] It has an enrollment of 32 people and is authorised.[1]

The Phase 3 study is also interventional and is authorised, with an enrollment of 220 people.[2] Its brief summary says the study is open-label, meaning both the participants and the research team know what treatment is being given.[2]

What researchers are measuring

The main outcome in the Phase 2 study is the change in IgA deposition in kidney tissue after 1 or 2 years of ZIGAKIBART treatment, compared with the level before treatment.[1] This tells researchers whether the amount of IgA buildup in the kidney tissue is changing over time.[1]

The Phase 3 study focuses on long-term safety and tolerability.[2] Its primary outcome includes the type, number, seriousness, and relatedness of treatment-emergent adverse events, as well as adverse events of special interest.[2]

Trial status and size

Both studies are listed as authorised in the source data.[1][2] The Phase 2 trial is smaller, with 32 participants, while the Phase 3 trial is larger, with 220 participants.[1][2] The different sizes fit the different goals of the studies, with one looking at kidney tissue changes and the other focusing on longer-term safety follow-up.[1][2]

Key patient terms

IgA nephropathy is the disease being studied in both trials.[1][2] IgA deposition means IgA buildup in kidney tissue, which is what the Phase 2 study measures.[1] Safety and tolerability mean how well the treatment is handled by the body and whether unwanted health problems happen over time.[2]

Adverse events are health problems seen during a study, and the Phase 3 trial tracks both general adverse events and those of special interest.[2] Open-label means there is no hiding of the treatment assignment in the study.[2]

Trial ID Phase Condition studied Status Enrollment
NCT07146906 Phase 2 IgA nephropathy Authorised 32
2024-519638-22-00 Phase 3 IgA nephropathy Authorised 220

FAQ

  • What condition are the ZIGAKIBART trials studying? The trials are studying IgA nephropathy, which is a kidney disease. One trial looks at changes in kidney tissue, and another looks at long-term safety.
  • Who can take part in these trials? Adults with IgA nephropathy are the main study population. One trial is for people who have already completed earlier ZIGAKIBART trials.
  • What phases are the ZIGAKIBART trials in? The trials listed are Phase 2 and Phase 3 studies. Phase 2 usually focuses on early effects, while Phase 3 often looks at larger safety and follow-up questions.
  • What are the trials trying to measure? One trial measures change in IgA deposition in kidney tissue after 1 or 2 years. The other measures treatment-emergent adverse events and adverse events of special interest.
  • Are these studies testing the same goal? No. One study is focused on kidney tissue changes, while the other is focused on long-term safety and tolerability. Together they help show how ZIGAKIBART is being evaluated in IgA nephropathy.

Ongoing Clinical Trials on ZIGAKIBART

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

    Recruiting

    2 1 1
    Investigated drugs:
    Czechia Germany Italy Poland Spain

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

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Croatia Czechia France Germany Greece +2

Glossary

  • IgA nephropathy: A kidney disease in which a protein called IgA builds up in the kidneys and can damage them over time.
  • Kidney tissue: The part of the kidney that is studied to see whether disease changes are improving or getting worse.
  • IgA deposition: The buildup of IgA in the kidney tissue. Trials may measure whether this buildup changes after treatment.
  • Phase 2: An earlier stage of clinical research that often looks at whether a treatment has a useful effect.
  • Phase 3: A later stage of clinical research that often includes more people and focuses strongly on safety and follow-up.
  • Interventional study: A study in which participants receive a treatment so researchers can observe its effects.
  • Open-label: A study design where participants and researchers know which treatment is being given.
  • Long-term safety: How safe a treatment is when it is used over a longer period of time.
  • Tolerability: How well people can take a treatment without major problems.
  • Treatment-emergent adverse events: Health problems that appear or get worse after treatment starts.
  • Adverse events of special interest: Side effects that researchers watch very closely because they are especially important for the study.

References