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

Study Identifier:
417-201-00060
ClinicalTrials.gov Identifier:
NCT06740526
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
844-687-8522 or [email protected]
Recruiting
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Study Details

Medical Condition
  • Autoimmune /Kidney Disease
Study Drug
  • Drug: Sibeprenlimab
Date
Nov 2024 - Apr 2029
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 16+ years
Requirements Information
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.

Protocol 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.

Study 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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Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
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.

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