Health Condition 1: N00-N99- Diseases of the genitourinary system
Conditions
Interventions
Intervention1: Sibeprenlimab (VIS649): The trial will evaluate a dose of 400 mg sibeprenlimab compared with placebo. The IMP will be administered SC once every 4 weeks (total of 26 doses
Control Inter
Sponsors
Otsuka Pharmaceutical Development Commercialization Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients greater than or equal to 18 years of age. 2. 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). 3. 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 at least 3 months prior to obtaining the initial screening urine collection. 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. 4. Screening urine protein/creatinine ratio (uPCR) greater than or equal to 0.75 g/g or urine protein greater than or equal to 1.0 g/day 5. eGFR greater than or equal to 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20-
Exclusion criteria
Exclusion criteria: 1. Secondary forms of IgAN or IgA vasculitis. 2. Coexisting chronic kidney disease other than IgAN. 3. Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable. 4. 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. 5. Nephrotic syndrome 6. Serum IgG 7. Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization 8. 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. 9. Chronic infectious disease, or acute infectious disease at time of screening. 10. Type 1 diabetes, or poorly controlled Type 2 diabetes 11. Uncontrolled hypertension The protocol provides additional information about these and other inclusion and exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary protein to creatinine ratio (uPCR) in a 24-hour collectionTimepoint: 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Annualized rate of change from baseline (slope) of eGFRTimepoint: Over 24 months;Proportion of subjects achieving urine total protein 1.0 g/day & at least 25% reduction from baselineTimepoint: At 12 months.;Annualized slope of eGFRTimepoint: Over 12 months | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Netherlands, Philippines, Poland, Portugal, Republic of Korea, Singapore, Spain, Sri Lanka, Taiwan, Thailand, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactDr Sahay Manisha
Osmania Hospital
Outcome results
None listed