Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue

Sponsor ID
417-201-00060
Clinicaltrials.gov ID
NCT06740526
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
844-687-8522 or [email protected]
Recruiting
Sponsor ID
417-201-00060
Trial Details
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Age
16+ years
Therapeutic Area
  • Autoimmune/Kidney Disease
    • Sex
    Female & Male
    Trial Dates
    Nov 2024 - Apr 2029
    Healthy Volunteers
    No
    • Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
    • Source-verified kidney biopsy confirmed diagnosis of IgAN.
    • Participant has estimated glomerular filtration rate (eGFR) \> 45 mL/min/1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration \[CKD EPI\] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 \[CKiD U25\] eGFR equation for those younger than 18 years)
    • 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.

    Study Summary

    This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.

    Additional Study Details

    Phase
    Phase 2
    Study Drug
    Drug: Sibeprenlimab
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    25
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • 1. Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
    • 2. Source-verified kidney biopsy confirmed diagnosis of IgAN.

    Exclusion Criteria

    • 1. Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
    • 2. Participant has coexisting chronic kidney disease, other than IgAN.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
    • Source-verified kidney biopsy confirmed diagnosis of IgAN.
    • Participant has estimated glomerular filtration rate (eGFR) \> 45 mL/min/1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration \[CKD EPI\] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 \[CKiD U25\] eGFR equation for those younger than 18 years)
    Exclusion Criteria:
    • 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.

    Locations

    Location
    Status
    Location
    Clinical Research Site 330
    Denver, Colorado, United States, 80230
    Status
    Recruiting
    Location
    Clinical Research Site 369
    Boston, Massachusetts, United States, 21144
    Status
    Recruiting
    Location
    Clinical Research Site 374
    Dakota Dunes, South Dakota, United States, 57409
    Status
    Recruiting
    Location
    Clinical Research Site 324
    Houston, Texas, United States, 77054
    Status
    Recruiting
    Location
    Clinical Research Site 305
    Scarborough Village, Ontario, Canada, M1H 3G4
    Status
    Recruiting

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    January 2026 01US25EUC0489

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