Impact of Sibeprenlimab on Kidney Tissue in IgA Nephropathy

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

This study is testing if a new treatment called sibeprenlimab can improve kidney tissue in people with IgA nephropathy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry-sponsored)
• Drugs / interventions: sibeprenlimab
• Locations: 5 sites (Denver, Colorado and 4 other locations)
• Trial ID: NCT06740526 on ClinicalTrials.gov

What this trial studies

This phase 2b open-label trial aims to evaluate the effects of sibeprenlimab on histopathological biomarkers in patients diagnosed with immunoglobulin A nephropathy (IgAN). Participants will undergo kidney biopsies to assess changes in kidney tissue in response to the treatment. The study will include individuals aged 16 and older with confirmed IgAN and a specific level of kidney function. The trial seeks to provide insights into the potential therapeutic benefits of sibeprenlimab for this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 16 and older with a confirmed diagnosis of IgA nephropathy and adequate kidney function.

Not a fit: Patients with other chronic kidney diseases or those currently on immunosuppressive therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve kidney health and outcomes for patients with IgA nephropathy.

How similar studies have performed: While this approach is being explored in this trial, similar studies have shown promise in targeting immunological pathways in kidney diseases.

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.

Where this trial is running

Denver, Colorado and 4 other locations

• Clinical Research Site 330 — Denver, Colorado, United States (Recruiting)
• Clinical Research Site 369 — Boston, Massachusetts, United States (Recruiting)
• Clinical Research Site 374 — Dakota Dunes, South Dakota, United States (Recruiting)
• Clinical Research Site 324 — Houston, Texas, United States (Recruiting)
• Clinical Research Site 305 — Scarborough Village, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Otsuka Call Center

Conditions IgA Nephropathy