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

RecruitingPhase 2Ages 16 Years - anyAllOtsuka Pharmaceutical Development & Commercializa…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Sibeprenlimab
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Where

5 sites
Clinical Research Site 330
Denver, United States
Clinical Research Site 369
Boston, United States
Clinical Research Site 374
Dakota Dunes, United States
Clinical Research Site 324
Houston, United States
Clinical Research Site 305
Scarborough Village, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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