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Clinical Trials in Canada / NCT06740526
Recruiting Phase 2

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

NCT06740526 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2024-11-19
Last updated
2025-04-06

Condition(s) studied

IgA Nephropathy

Investigational drug(s) / intervention(s)

Sibeprenlimab →

Sibeprenlimab: Sibeprelimab SC (Period 1) Sibeprelimab SC (Period 2)

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.

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)

Trial sites (5)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT06740526 on ClinicalTrials.gov ↗ ← All trials in Canada