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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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 has uncontrolled hypertension (defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg).

Trial design

Treatments tested in this trial

  • Sibeprenlimab

Treatment groups

25 Participants
are divided into 1 treatment group