Actively Recruiting
A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
Led by Novartis Pharmaceuticals · Updated on 2026-04-01
32
Participants Needed
8
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
CONDITIONS
Official Title
A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary IgAN confirmed by kidney biopsy within 5 years before screening
- eGFR of 45 mL/min/1.73 m2 or higher at screening
- Persistent proteinuria defined as either total urine protein 0.5 g/day or more or UPCR 0.5 g/g or more in a 24-hour urine collection despite therapy, or newly diagnosed IgAN with proteinuria over 1.5 g/day or UPCR over 1.5 g/g
- Body weight of at least 45 kg and BMI of 35.0 kg/m2 or less at screening
You will not qualify if you...
- Secondary forms of IgAN, IgA vasculitis, other nephropathies, or chronic urinary tract disorders
- Total IgG less than 6.0 g/L at screening
- Chronic urinary tract disorders including retention, incontinence, or recurrent infections
- Untreated or uncontrolled hypertension despite treatment
- Use of complement pathway inhibitors, mycophenolic acids, systemic calcineurin inhibitors, corticosteroids, immunosuppressants, or immunomodulatory agents within 12 months before screening
- Acute kidney injury within 4 weeks before screening
- Current or past treatment with anti-APRIL monoclonal antibodies or dual APRIL/BAFF inhibitors for more than 3 consecutive months
- Planned start or recent start (within 24 weeks) of glucagon-like peptide-1 agonist treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Colorado Kidney Care Nephrology
Denver, Colorado, United States, 80230
Actively Recruiting
2
American Clinical Trials
Acworth, Georgia, United States, 30101
Actively Recruiting
3
Inter Med Consultants
Edina, Minnesota, United States, 55435
Actively Recruiting
4
Novartis Investigative Site
Shanghai, China, 200025
Actively Recruiting
5
Novartis Investigative Site
Kawasaki, Kanagawa, Japan, 213-8587
Actively Recruiting
6
Novartis Investigative Site
Miyazaki, Japan, 889-1692
Actively Recruiting
7
Novartis Investigative Site
Seoul, Korea, South Korea, 03080
Actively Recruiting
8
Novartis Investigative Site
Taipei, Taiwan, 10002
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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