Zigakibart for Immunoglobulin A Nephropathy

Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.

Recruiting Phase 3 Interventional Study
Kidney Diseases Kidney Diseases, Chronic Urological Diseases Glomerulonephritis Glomerular Disease Glomerulonephritis, IGA Glomerulopathy Immunoglobulin Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for

This trial is looking for adults who have completed another zigakibart study. Participants will receive zigakibart treatment to see if it is safe and effective for long-term use in their condition.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have completed a previous study involving zigakibart.
  • I am an adult who can give informed consent.
  • My doctor thinks I could benefit from zigakibart treatment.

You may not be able to join if

  • I withdrew early from a previous zigakibart study.
  • I have been on dialysis for more than 30 days.
  • I need a kidney transplant.
  • I have a recent serious kidney injury.
  • I have a severe infection right now.
  • I have recently had a live vaccination.
  • I am pregnant or breastfeeding.
  • I have certain serious health issues according to my doctor.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the OLE study. 2. Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol. 3. Per Investigator's clinical judgment, …
Contacts

Novartis Pharmaceuticals

1-888-669-6682

novartis.email@novartis.com

CONTACT

Novartis Pharmaceuticals

+41613241111

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