IgA Nephropathy
Conditions
Brief summary
Primary Efficacy: Ratio of uPCR at 9 months compared with baseline, based on 24-hour urine collection.
Detailed description
The annualized slope of eGFR estimated over the course of approximately 24 months., Efficacy: Mean change of eGFR from baseline at 24 months., Efficacy: Progression to CKF, as assessed by: Time to progression to CKF (time from the randomization date to first occurrence of CKF); Proportion of subjects with progression to CKF., Change from baseline in total serum IgA, IgG, and IgM concentration, Safety: Incidence of TEAEs graded by severity, clinical laboratory tests, vital sign measurements, 12 lead ECGs, physical examinations, and injection site reactions., Other: Evaluation of serum ADA.
Interventions
DRUGSibeprenlimab-matching Placebo
DRUGSibeprenlimab
Sponsors
Otsuka Pharmaceutical Development And Commercialization Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy: Ratio of uPCR at 9 months compared with baseline, based on 24-hour urine collection. | — |
Secondary
| Measure | Time frame |
|---|---|
| The annualized slope of eGFR estimated over the course of approximately 24 months., Efficacy: Mean change of eGFR from baseline at 24 months., Efficacy: Progression to CKF, as assessed by: Time to progression to CKF (time from the randomization date to first occurrence of CKF); Proportion of subjects with progression to CKF., Change from baseline in total serum IgA, IgG, and IgM concentration, Safety: Incidence of TEAEs graded by severity, clinical laboratory tests, vital sign measurements, 12 lead ECGs, physical examinations, and injection site reactions., Other: Evaluation of serum ADA. | — |
Countries
Belgium, Croatia, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Spain
Outcome results
None listed