A Phase 3 interventional study of Sibeprenlimab and Standard of care in IgA Nephropathy, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Not yet recruiting. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 3, Interventional, and Treatment
This Phase 3, open-label study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of sibeprenlimab administered subcutaneously every 4 weeks in pediatric participants aged 2 to 17 years with IgA nephropathy (IgAN). Sibeprenlimab will be administered as an add-on to standard of care therapy consisting of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs).
275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.
This study's planned enrollment of 24 is below the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.
Browse Glomerulonephritis, IGA studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 295 studies on the registry; 18 are open to participants now.
Of its 106 completed or terminated interventional studies of FDA-regulated products, 71 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks as an add-on to standard of care treatment at a weight-based dose.
Drug: Sibeprenlimab · Drug: Standard of care
Sibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks at a weight-based dose
Standard of care therapy consists of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs)
Ratio of Urine Protein-to-Creatinine Ratio (uPCR) at Week 40 Compared With Baseline Using First-void Spot Urine Samples
Time frame: Baseline, Week 40
Serum Concentration of Sibeprenlimab Through Week 52
Time frame: Baseline through Week 52
Change From Baseline in Serum Immunoglobulin A (IgA) Through Week 52
Time frame: Baseline through Week 52
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Study Discontinuations Due to Adverse Events Through Week 60
Time frame: Baseline through Week 60
Number of Participants With Clinically Significant Changes in Vital Signs Through Week 60
Time frame: Baseline through Week 60
Number of Participants With Clinically Significant Changes in Physical Examination Findings Through Week 60
Time frame: Baseline through Week 60
Number of Participants With Clinically Significant Changes in Laboratory Assessments Through Week 60
Laboratory assessments include hematology, serum chemistry, and urine laboratory parameters.
Time frame: Baseline through Week 60
Number of Injection Site Reactions Through Week 52
Time frame: Baseline through Week 52
Number of Participants With Anti-Drug Antibody (ADA) From Baseline Through Week 60
Time frame: Baseline through Week 60
No study locations are listed for this record.
Plan to share: Yes — Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Access criteria: Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
Data sharing details ↗ · clinical-trials.otsuka.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sibeprenlimab
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