Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

JRCT ID: jRCT2031220114

Registered date:04/06/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Immunoglobulin A Nephropathy
• Date of first enrollment: 14/11/2022
• Target sample size: 470
• 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 400mg or Placebo s.c. q 4 week

Outcome(s)

• Primary Outcome: Primary Efficacy: Ratio of uPCR at 9 months compared with baseline, based on 24-hour urine collection.

Key inclusion & exclusion criteria

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

Include criteria

- Male and female patients >= 18 years of age .
- Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit).
- Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated >= 3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements.
- Screening urine protein/creatinine ratio (uPCR) >= 0.75 g/g or urine protein >= 1.0 g/day
- eGFR >= 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- <30 mL/min/1.73 m2), calculated using the CKD-EPI equation.)

Exclude criteria

- Secondary forms of IgAN or IgA vasculitis.
- Coexisting chronic kidney disease other than IgAN.
- Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable.
- Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, or crescents in > 25% of glomeruli is exclusionary. This does not apply to the exploratory cohort.
- Nephrotic syndrome
- Serum IgG < 600 mg/dL at screening.
- Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization
- Participation in another interventional clinical trial and receipt of another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
- Chronic infectious disease, or acute infectious disease at time of screening.
- Type 1 diabetes, or poorly controlled Type 2 diabetes
- Uncontrolled hypertension

Related Information

• Primary Sponsor: Moriguchi Minoru
• Secondary ID(s): NCT05248646