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.
Eligibility
Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
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.
3. 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.
Primary outcome measure(s)
Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52 — From Baseline to Week 52
Trial sites (5)
Facility
City
Region
Status
Clinical Research Site 330
Denver
Colorado
Recruiting
Clinical Research Site 369
Boston
Massachusetts
Recruiting
Clinical Research Site 374
Dakota Dunes
South Dakota
Recruiting
Clinical Research Site 324
Houston
Texas
Recruiting
Clinical Research Site 305
Scarborough Village
Ontario
Recruiting
More Otsuka Pharmaceutical Development & Commercialization, Inc. trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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