Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
Recruiting now · Phase 2
Conditions studied: IgA Nephropathy
In brief
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.
Key facts
- Study ID
- NCT06740526
- Run by
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- People needed
- 25
- Starts
- 2024-11-19
- Expected to finish
- 2029-04-17
- Last updated by the study team
- 2025-04-06
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Clinical Research Site 330 — Denver, Colorado, United States (enrolling)
- Clinical Research Site 369 — Boston, Massachusetts, United States (enrolling)
- Clinical Research Site 374 — Dakota Dunes, South Dakota, United States (enrolling)
- Clinical Research Site 324 — Houston, Texas, United States (enrolling)
- Clinical Research Site 305 — Scarborough Village, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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