Phase 3 study · Otsuka
Otsuka's phase 3 sibeprenlimab study in children and teens for IgA nephropathy
About 24 children and teens ages 2 to 17 are planned. Every participant gets sibeprenlimab, a shot under the skin every 4 weeks for 48 weeks at a dose based on weight, added to their usual treatment. There is no placebo.
Free email alert
Hear when Otsuka's phase 3 sibeprenlimab study in children and teens opens near you
One email when it starts enrolling or lists a new site, with the sites and how to reach the study team. Nothing else.
Opening and new sites for this study only. Stop anytime. We never share your email. Privacy policy
Check the main requirements privately
These questions restate the study's public listing in plain words. Your answers stay on this device and are never sent. You can print a one-page summary to go over with your nephrologist. Only the study team decides who can join.
1. Is your child between 2 and 17 years old?
2. Has a kidney biopsy confirmed your child's IgA nephropathy?
3. Has your child taken an ACE inhibitor or ARB at the highest dose they can handle, steadily, for at least 12 weeks?
4. Is your child's urine protein-to-creatinine ratio (UPCR) at least 0.75g/g?
The study measures this itself during screening. Your child's nephrologist can tell you the latest number.5. Is your child's eGFR, the kidney filtering number, 30 or higher?
6. Does your child have another kind of chronic kidney disease besides IgA nephropathy?
The study team also checks for these, which are easier to go over with your nephrologist:
- An IgG antibody blood level of at least 600mg/dL at screening
- If your child takes an SGLT2 inhibitor, it must have been started at least 12 weeks before
Sites and contact
No US sites are listed yet. Follow the study above and we'll email you the day sites are added.
The listing names this contact: Otsuka Call Center, 844-687-3522, Otsuka-ProfessionalServices@otsuka-us.com.
From the public ClinicalTrials.gov record NCT07770815, last updated there 2026-10-15. Questions checked against the listing on November 9, 2026. Trial Friend is independent of this study and its sponsor, and is not a medical provider. Nothing here is medical advice; talk with your doctor about whether a study is right for you.