Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

JRCT ID: jRCT2031220273

Registered date:15/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Immunoglobulin A Nephropathy
• Date of first enrollment: 19/10/2022
• Target sample size: 600
• Countries of recruitment: Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czech Republic,Japan,France,Japan,Germany,Japan,Hong Kong,Japan,Hungary,Japan,India,Japan,Israel,Japan,Italy,Japan,Malaysia,Japan,Netherlands,,Japan,Philippines,Japan,Poland,Japan,Portugal,Japan,Singapore,Japan,Spain,Japan,Sri Lanka,Japan,Taiwan,Japan,Thailand,Japan,United Kingdom,Japan,United States,Japan,Vietnam,Japan,Korea,Japan,Croatia,Japan,Greece,Japan
• Study type: Interventional
• Intervention(s): Sibeprenlimab 400 mg s.c. q 4 weeks

Outcome(s)

• Primary Outcome: Incidence of TEAEs graded by severity and as assessed by clinical laboratory tests, vital sign measurements, physical examinations, and injection site reactions.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Subjects who completed Trial 417-201-00007 or VIS649-201 without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab.
2) eGFR >= 20 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Exclude criteria

1) Subjects who have not completed participation in trials 417-201-00007 or VIS649-201.
2) Subjects who, following enrollment in trials 417-201-00007 or VIS649-201 developed a condition or characteristic that would have excluded them from participation in these trials.

Related Information

• Primary Sponsor: Moriguchi Minoru
• Secondary ID(s): NCT05248659