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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.
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

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Britanco de Buenos Aires
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Buenos AiresArgentinaUnknown status
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
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Buenos AiresArgentinaUnknown status
Hamilton Centre for Kidney Research (HCKR)
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HamiltonCanadaUnknown status
OTT Healthcare
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Scarborough VillageCanadaUnknown status
St. Paul's Hospital
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VancouverCanadaUnknown status
Leicester General Hospital
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LeicesterUnited KingdomUnknown status
King's College Hospital NHS Foundation Trust
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LondonUnited KingdomUnknown status
Kyushu University Hospital
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FukuokaJapanUnknown status
Nara Medical University Hospital
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KashiharaJapanUnknown status
Kobe University Hospital
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KobeJapanUnknown status
University of Miyazaki Hospital
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MiyazakiJapanUnknown status
Juntendo University Hospital
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TokyoJapanUnknown status
Juntendo University Urayasu Hospital
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UrayasuJapanUnknown status
University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Massachusetts General Hospital (MGH) / Harvard
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BostonUnited StatesUnknown status
Dakota Dunes
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Dakota DunesUnited StatesUnknown status
Colorado Kidney Care PC
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DenverUnited StatesUnknown status
Prolato Clinical Research Center
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HoustonUnited StatesUnknown status
Stanford University Medical Center
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StanfordUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.