IgA NephropathyPhase 2NCT06740526
Phase 2b Open-Label Repeat Kidney Biopsy Study
A Phase 2 study testing Sibeprenlimab in people with IgA Nephropathy, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 19 sites in 5 countries.
Trial summary
Assess impact of sibeprenlimab on IgA deposition and other histological endpoints in kidney tissue at Week 52 relative to baseline Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Sibeprenlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 5 Dec 2024to 28 Dec 2028
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be at least 18 years of age or older at the time of signing the informed consent/assent.
- Source-verified kidney biopsy confirmed diagnosis of IgAN.
- Participant has eGFR > 45 mL/min/1.73 m2 using serum creatinine based on CKD-EPI 2021 equation. Serum creatinine assessments for the determination of eGFR should be taken when the participant is considered to be in a steady state without recent changes in volume status, medications that could impact the result (eg, nonsteroidal anti-inflammatory drugs [NSAIDs], aminoglycosides, trimethoprim, cimetidine, pyrimethamine, fenofibrate, or creatine supplements), or changes in dietary protein intake.
Who cannot join
- Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
- Participant has coexisting chronic kidney disease, other than IgAN.
- Participant has a serum IgG value <600 mg/dL at screening.
- Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note:
- topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids are allowed).
- Participant has uncontrolled hypertension (defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg).
- Participants who would be likely to require prohibited concomitant therapy during the trial.
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
United States6 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital (MGH) Harvard
Boston, Massachusetts, 21144
Dakota Dunes
Dakota Dunes, South Dakota, 57409
Colorado Kidney Care PC
Denver, Colorado, 80220
Prolato Clinical Research Center
Houston, Texas, 77054
Stanford University Medical Center
Stanford, California, 94305
Japan6 sites
Kyushu University Hospital
Fukuoka, 812-8582
Nara Medical University Hospital
Kashihara, Nara, 634-8522
Kobe University Hospital
Kobe, Hyōgo, 650-0017
University of Miyazaki Hospital
Miyazaki, 889-1692
Juntendo University Hospital
Tokyo, 113-8431
Juntendo University - Urayasu Hospital
Urayasu, Chiba, 279-0021
Canada3 sites
Hamilton Centre for Kidney Research (HCKR)
Hamilton, Ontario, L8N 4A6
OTT Healthcare
Scarborough Village, Ontario, M1H 3G4
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Argentina2 sites
Hospital Britanco de Buenos Aires
Buenos Aires, C1280AEB
Centro Medico Dra Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425
United Kingdom2 sites
Leicester General Hospital
Leicester, LE5 4PW
King's College Hospital NHS Foundation Trust
London, SW9 8RR
About this study
Official title: A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies Adults With Immunoglobulin A Nephropathy
Assess impact of sibeprenlimab on IgA deposition and other histological endpoints in kidney tissue at Week 52 relative to baseline
- Conditions
- IgA Nephropathy
- Being tested
- Sibeprenlimab
- 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
Sibeprelimab SC (Period 1)
Sibeprelimab SC (Period 2)
| Study group | Role | What they receive |
|---|---|---|
| Sibeprenlimab | Experimental | Not described Receives: Drug: Sibeprenlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52
Measured: From Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start5 Dec 2024
- Primary completion28 Dec 2028 (estimated)
- Study completion28 Dec 2028 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740526
- Sponsor's protocol ID
- 417-201-00060
- Status last verified
- Oct 2026
- First submitted
- 13 Dec 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies Adults With Immunoglobulin A Nephropathy
- ClinicalTrials.gov ID
- NCT06740526
- Acronym / sponsor ID
- 417-201-00060
- Conditions
- IgA Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 28 Dec 2028 (estimated)
- Study completion
- 28 Dec 2028 (estimated)
- First posted
- 18 Dec 2024 (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.
Assess impact of sibeprenlimab on IgA deposition and other histological endpoints in kidney tissue at Week 52 relative to baseline
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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be at least 18 years of age or older at the time of signing the informed consent/assent.
- Source-verified kidney biopsy confirmed diagnosis of IgAN.
- Participant has eGFR > 45 mL/min/1.73 m2 using serum creatinine based on CKD-EPI 2021 equation. Serum creatinine assessments for the determination of eGFR should be taken when the participant is considered to be in a steady state without recent changes in volume status, medications that could impact the result (eg, nonsteroidal anti-inflammatory drugs [NSAIDs], aminoglycosides, trimethoprim, cimetidine, pyrimethamine, fenofibrate, or creatine supplements), or changes in dietary protein intake.
Key exclusion criteria (7 listed)
- Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
- Participant has coexisting chronic kidney disease, other than IgAN.
- Participant has a serum IgG value <600 mg/dL at screening.
- Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note:
- topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids are allowed).
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 |
|---|---|---|
| SibeprenlimabSibeprelimab SC (Period 1) Sibeprelimab SC (Period 2) | Drug | Sibeprenlimab |
Primary outcome
Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52
Time frame: From Baseline to Week 52
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 27 Oct 2026.
- 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.
Related trials for IgA Nephropathy
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
Primary IgA Nephropathy
Not yet recruitingPhase 1
A Food-Effect Study of Budesonide Delayed Release Tablet (D23A) in Healthy Chinese Participants
IgA Nephropathy
RecruitingPhase 2
A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN
Immunoglobulin A Nephropathy (IgAN)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sibeprenlimab in people with IgA Nephropathy, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Japan, Canada, Argentina, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52 (time frame: From Baseline to Week 52). 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 27 Oct 2026.