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

Launched by OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC. · Dec 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called sibeprenlimab on a kidney condition known as immunoglobulin A nephropathy (IgAN). The goal is to see how this treatment might change certain markers of the disease in kidney tissue. The trial is currently recruiting participants who are 16 years or older and have been diagnosed with IgAN through a kidney biopsy. To qualify, participants must also have a certain level of kidney function, measured by a test called eGFR.

If you decide to participate, you will receive sibeprenlimab, and the researchers will monitor your health and kidney tissue for any changes. However, there are some important criteria to consider: you cannot be pregnant or breastfeeding, have other types of chronic kidney disease, or be on certain medications that could interfere with the trial. This study will help understand how sibeprenlimab works and may contribute to better treatments for IgAN in the future.

Gender

ALL

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.