NCT06740526Active, not recruitingPhase 2
Phase 2b Open-Label Repeat Kidney Biopsy Study
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
Assess impact of sibeprenlimab on IgA deposition and other histological endpoints in kidney tissue at Week 52 relative to baseline
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 13 Dec 2024
- Start date
- 5 Dec 2024
- Primary completion date
- 28 Dec 2028
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Diseases
- IgA nephropathy
- NCT number
- NCT06740526
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 56
- From 5 Dec 2024 to the primary completion date, 28 Dec 2028
- 19 sites in 5 countries
- 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.
Prior treatment
- Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
- 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).
- Participants who would be likely to require prohibited concomitant therapy during the trial.
Other illness
- Participant has coexisting chronic kidney disease, other than IgAN.
- Participant has uncontrolled hypertension (defined as systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg).
Lab values
- Participant has a serum IgG value \<600 mg/dL at screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Britanco de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hamilton Centre for Kidney Research (HCKR) Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| OTT Healthcare Coordinator of this site? Confirm its status | Scarborough Village | Canada | Unknown status |
| St. Paul's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Leicester General Hospital Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| King's College Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Nara Medical University Hospital Coordinator of this site? Confirm its status | Kashihara | Japan | Unknown status |
| Kobe University Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| University of Miyazaki Hospital Coordinator of this site? Confirm its status | Miyazaki | Japan | Unknown status |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Juntendo University Urayasu Hospital Coordinator of this site? Confirm its status | Urayasu | Japan | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Massachusetts General Hospital (MGH) / Harvard Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Dakota Dunes Coordinator of this site? Confirm its status | Dakota Dunes | United States | Unknown status |
| Colorado Kidney Care PC Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Prolato Clinical Research Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Stanford University Medical Center Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
Related publications
- The Oxford Classification Should Remain the Gold Standard for Classification of IgA Nephropathy: CON.Kidney360 · 2026 · PMID 41661687
This page is information, not medical advice. Discuss any trial with your doctor.