Under construction – not a live service
Sign in
Taking peoplePhase 2

Tests zigakibart in adults with IgA nephropathy, a kidney disease

Tests zigakibart in adults with IgA nephropathy, a kidney disease that progresses over time.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Lodz, Opole, and Warsaw, PolandSee the 3 sitesAlso in 10 other countries, 27 sites
Trial code
Registry title
A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
Status
Recruiting
Phase
Phase 2
People taking part
32 people, planned
Started
26 Mar 2026
Expected to end
18 Oct 2030
Type of study
Interventional
Treatments tested
  • zigakibart
Record updated
21 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with primary IgA nephropathy confirmed by kidney biopsy, who still have protein in the urine and fairly good kidney function.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Primary IgA nephropathy confirmed by kidney biopsy within 5 years before screening. eGFR ≥45 mL/min/1.73 m2. Ongoing protein in the urine: total urine protein ≥0.5 g/day or UPCR ≥0.5 g/g despite supportive therapy, or a diagnosis less than 6 months ago with total urine protein >1.5 g/day or UPCR >1.5 g/g.
Earlier treatment
People cannot have had complement pathway inhibitors, mycophenolic acids, systemic calcineurin inhibitors, corticosteroids or immunosuppressive or immunomodulatory agents within 12 months before screening. People cannot have had anti-APRIL antibodies or dual APRIL/BAFF inhibitors for more than 3 months in a row. Those with persistent protein in urine must have had the maximally tolerated dose of supportive therapy, or poorly tolerated supportive therapy.
Biomarker or test result
Total urine protein ≥0.5 g/day or UPCR ≥0.5 g/g in a 24-hour urine collection. Body weight ≥45 kg (99 lb) and BMI ≤35.0 kg/m2.

Main reasons for not taking part

  • IgAN caused by another condition, IgA vasculitis, or any other kidney disease
  • Total IgG <6.0 g/L at screening
  • Any long-term urinary tract problem, such as retention, incontinence or repeated urinary infections
  • Average blood pressure above 150 mmHg (top number) or 90 mmHg (bottom number)
  • Acute kidney injury within 4 weeks before screening

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Primary IgAN, confirmed by kidney biopsy, within 5 years prior to Screening
  • eGFR ≥45 mL/min/1.73 m2, based on the 2021 CKD-EPI equation, at Screening
  • Persistent proteinuria, defined as either; Total Urine Protein ≥0.5 g/day or UPCR ≥0.5 g/g in a 24-hour urine collection, at Screening, despite maximally tolerated dose or poorly tolerated supportive therapy or; IgAN diagnosis <6 months prior to Screening with Total Urine Protein >1.5 g/day or UPCR >1.5 g/g in a 24-hour urine collection, at the time of clinical presentation or diagnosis
  • Body weight ≥45 kg and body mass index (BMI) ≤35.0 kg/m2, at Screening

Who cannot take part

  • Treatment with complement pathway inhibitors, mycophenolic acids, systemic calcineurin inhibitors or corticosteroids, immunosuppressive or immunomodulatory agents within 12 months prior to screening
  • Acute kidney injury (AKI), defined by AKI network criteria, within 4 weeks prior to screening
  • Current treatment with anti-APRIL monoclonal antibodies or dual APRIL/BAFF inhibitors or past treatment of the same at any time for >3 consecutive months prior to screening
  • Planned initiation of, or recently (within 24 weeks) initiated, treatment with glucagon-like peptide-1 agonists at screening; Other protocol-defined inclusion/exclusion criteria may apply
  • Secondary forms of IgAN, as determined by the Investigator, diagnosis of IgA vasculitis, or any other nephropathy or chronic urinary tract disorder
  • Any chronic urinary tract disorder, including but not limited to retention, incontinence, and/or recurrent urinary tract infections
  • Total IgG <6.0 g/L at screening
  • An average systolic blood pressure >150 mmHg or average diastolic blood pressure >90 mmHg based on three measurements at Screening

Where in Poland

Also in 10 other countries, 27 sites

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W LodziLodz, PolandNot yet recruiting
  • Uniwersytecki Szpital Kliniczny w OpoluOpole, PolandNot yet recruiting
  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu MedycznegoWarsaw, PolandNot yet recruiting

About the trial

What the trial wants to find out

The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.

The group in the trial

  • zigakibartTreatment being tested

    zigakibart injections every second week for two years

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
An Open-label, Multicenter Study to Assess the Effect of Zigakibart Treatment on Histologic, Circulating, and Excreted Markers of Kidney Disease and Dysfunction in Adult Patients With IgA Nephropathy.
Plain-language title
Tests zigakibart in adults with IgA nephropathy, a kidney diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
21 October 2026