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Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
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
Who can join
Ages 16 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Sibeprenlimab (drug)
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Participants: 25 · Started: Nov 19, 2024
Contact the study team
- Otsuka Call Center · Phone: 844-687-8522
Official record on ClinicalTrials.gov — NCT06740526
Locations in the U.S.
| Colorado | Clinical Research Site 330, Denver |
| Massachusetts | Clinical Research Site 369, Boston |
| South Dakota | Clinical Research Site 374, Dakota Dunes |
| Texas | Clinical Research Site 324, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.