Actively Recruiting
An Open-label, Multicenter Study to Assess the Effect of Zigakibart Treatment on Kidney Disease Markers in Adults With IgA Nephropathy
Led by Novartis Pharmaceuticals · Updated on 2026-05-27
32
Participants Needed
9
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of zigakibart on the progression of Immunoglobulin A Nephropathy (IgAN), a kidney disease. This open-label, multicenter Phase 2 study involves adult patients with confirmed primary IgAN. Participants are randomized into two groups that differ only by the timing of a kidney biopsy, either at the end of the first or second year of treatment. Participants will receive zigakibart injections of 600 mg under the skin every two weeks for up to two years. The study includes a screening period of up to 8 weeks, followed by 104 weeks of treatment, and a safety follow-up period of 13 weeks. The treatment effects will be monitored through kidney biopsies and various markers of kidney disease. During the study, participants will undergo assessments including kidney biopsies, blood and urine tests to evaluate kidney function and disease markers, and safety monitoring for adverse events. Researchers will measure changes in IgA deposition in the kidneys, proteinuria, kidney filtration rate, and other blood markers over time. The total duration of participation may be up to 125 weeks, including screening, treatment, and follow-up.
CONDITIONS
Brief Title
A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 100 years
- Primary Immunoglobulin A Nephropathy confirmed by kidney biopsy within 5 years prior to screening
- Estimated glomerular filtration rate (eGFR) of at least 45 mL/min/1.73 m2 at screening
- Persistent proteinuria defined as total urine protein of at least 0.5 g/day or urine protein-to-creatinine ratio of at least 0.5 g/g at screening despite supportive therapy, or IgAN diagnosis within 6 months with higher protein levels
- Body weight of at least 45 kg and body mass index (BMI) of 35.0 kg/m2 or less at screening
You will not qualify if you...
- Secondary forms of IgAN, IgA vasculitis, or other nephropathy or chronic urinary tract disorders
- Total IgG less than 6.0 g/L at screening
- Any chronic urinary tract disorder including retention, incontinence, or recurrent infections
- Average systolic blood pressure over 150 mmHg or diastolic over 90 mmHg at screening
- Treatment with complement pathway inhibitors, mycophenolic acids, systemic calcineurin inhibitors, corticosteroids, or immunosuppressive agents within 12 months prior to screening
- Acute kidney injury within 4 weeks prior to screening
- Current or past treatment with anti-APRIL monoclonal antibodies or dual APRIL/BAFF inhibitors exceeding 3 consecutive months prior to screening
- Planned or recent initiation of glucagon-like peptide-1 agonists within 24 weeks prior to screening
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - up to 8 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 104 weeks
Participants receive zigakibart injections every second week for up to 104 weeks (2 years).
Bi-weekly injections for 2 years
Duration - 13 weeks
Participants are monitored for safety after completing treatment.
Periodic visits during follow-up
Trial Site Locations
Total: 9 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
Opole, Poland, 45-401
Actively Recruiting
8
Novartis Investigative Site
Seoul, Seoul, South Korea, 03080
Actively Recruiting
9
Novartis Investigative Site
Taipei, Taiwan, 10002
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
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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