NCT07770815Not yet recruitingPhase 3
Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN)
A Phase 3, Open-label, Single-arm, Repeat-dose Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Sibeprenlimab Administered Subcutaneously in Children and Adolescents With Immunoglobulin A Nephropathy
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 13 Aug 2026
- Start date
- 30 Oct 2026
- Primary completion date
- 29 Dec 2029
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Diseases
- IgA nephropathy
- NCT number
- NCT07770815
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 24
- From 30 Oct 2026 to the primary completion date, 29 Dec 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Source-verified, biopsy-confirmed IgA nephropathy (IgAN).
- Receiving a stable and maximally tolerated dose of authorized angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) for at least 12 weeks.
- Participants receiving a stable dose of sodium-glucose cotransporter-2 inhibitor (SGLT2i) therapy for IgAN, if available, in addition to ACEIs and/or ARBs, must have initiated SGLT2i treatment for at least 12 weeks.
- Participants must have a urine protein/creatinine ratio (uPCR) ≥ 0.75 grams per gram (g/g), as measured from the geometric mean of 3 first void spot urine samples (collected within the screening window prior to Dose 1).
- Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2).
- No evidence of coexisting chronic kidney disease other than IgAN.
- Serum immunoglobulin G (IgG) ≥ 600 mg/dL at screening.
- Kidney biopsy findings not demonstrating additional pathological features inconsistent with IgAN.
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.