A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults With Immunoglobulin A Nephropathy

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. To Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults With Immunoglobulin A Nephropathy

CT.gov Identifier
NCT06740526
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Otsuka Holdings/Otsuka Pharmaceutical
Collaborator
N/A
Study Contact Information
+81 3 6717 1410
Recruiting
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Study Details

Diseases
IgA nephropathy
Study Drug
Sibeprenlimab
Genes
N/A
Study Dates
Nov 2024 - Apr 2029
Sex
Female & Male
Age
16+ years
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:
  • 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.
  • 3. Participant has a serum IgG value \<600 mg/dL at screening.
  • 4. 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).
  • 5. Participant has uncontrolled hypertension (defined as systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg).
  • 6. 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.

To Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults With Immunoglobulin A Nephropathy

Study Locations

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