IgA NephropathyPhase 3NCT07770815
Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN)
A Phase 3 study testing Sibeprenlimab in people with IgA Nephropathy, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
Trial summary
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). Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Sibeprenlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 23 Feb 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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).
- Conditions
- IgA Nephropathy
- Being tested
- Sibeprenlimab, Standard of care
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SibeprenlimabDrug
Sibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks at a weight-based dose
Standard of careDrug
Standard of care therapy consists of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs)
| Study group | Role | What they receive |
|---|---|---|
| Sibeprenlimab | Experimental | 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. Receives: Drug: Sibeprenlimab; Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Urine Protein-to-Creatinine Ratio (uPCR) at Week 40 Compared With Baseline Using First-void Spot Urine Samples
Measured: Baseline, Week 40
Serum Concentration of Sibeprenlimab Through Week 52
Measured: Baseline through Week 52
Change From Baseline in Serum Immunoglobulin A (IgA) Through Week 52
Measured: Baseline through Week 52
Secondary outcomes (6)
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Study Discontinuations Due to Adverse Events Through Week 60
Measured: Baseline through Week 60
Number of Participants With Clinically Significant Changes in Vital Signs Through Week 60
Measured: Baseline through Week 60
Number of Participants With Clinically Significant Changes in Physical Examination Findings Through Week 60
Measured: 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.
Measured: Baseline through Week 60
Number of Injection Site Reactions Through Week 52
Measured: Baseline through Week 52
Number of Participants With Anti-Drug Antibody (ADA) From Baseline Through Week 60
Measured: Baseline through Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start30 Oct 2026 (estimated)
- Primary completion29 Dec 2029 (estimated)
- Study completion23 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770815
- Sponsor's protocol ID
- 417-201-00009
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07770815
- Acronym / sponsor ID
- 417-201-00009
- Conditions
- IgA Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 29 Dec 2029 (estimated)
- Study completion
- 23 Feb 2030 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sibeprenlimab | Experimental | Drug: Sibeprenlimab, Drug: Standard of careSibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks as an add-on to standard of care treatment at a weight-based dose. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SibeprenlimabSibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks at a weight-based dose | Drug | Sibeprenlimab |
| Standard of careStandard of care therapy consists of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) | Drug | Sibeprenlimab |
Primary outcome
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
6 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Otsuka Clinical Trials WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sibeprenlimab in people with IgA Nephropathy, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Otsuka Call Center (844-687-3522, Otsuka-ProfessionalServices@otsuka-us.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.