IgA nephropathy
Conditions
Interventions
Drug: Povetacicept
Povetacicept is administered by subcutaneous injection.
Drug: placebo
Placebo is matched to Povetacicept subcutaneous injection administration.
Sponsors
Yoshimoto Sachiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only the main criteria are listed 1) Diagnosed IgAN, with biopsy confirmation and biopsy report available for the review by investigator 2) The arithmetic mean of proteinuria excretion >=1.0 g/day or 24-hour urine protein creatinine ratio (uPCR) >=0.75 g/g on two 24-hour urine samples 3) Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73m2 (main cohort) or 20 to <30 mL/min/1.73m2 (exploratory cohort) 4) The arithmetic mean of two resting systolic blood pressure measurements in the same arm on the same day <=150 mmHg and resting diastolic blood pressure <=90 mmHg 5) Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB) as per protocol specification 6) Other protocol defined Inclusion criteria may apply
Exclusion criteria
Exclusion criteria: Only the main criteria are listed 1) Have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, B cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol 2) Rapidly progressive glomerulonephritis with eGFR reduction >50% within 12 weeks of the start of screening 3) Unstable neuropsychiatric disorders, including any history of suicidal ideation or behavior, within 24 weeks of the first screening visit 4) Severe hypersensitivity or anaphylactic reaction to any of the ingredients of the investigational drug 5) Pregnant or breastfeeding at the time of screening or planning to become pregnant <=12 weeks following the last dose of the investigational drug 6) Other protocol defined Exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in 24-hour urine protein to creatinine ratio (uPCR) at Week 36 Total estimated glomerular filtration rate (eGFR) slope through Week 104 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in serum Gd-IgA1 at Week 36 Proportion of subjects to achieve hematuria resolution at Week 36 (among subjects with hematuria at baseline) Change from baseline in eGFR at Week 104 Time to kidney disease progression, defined as =>30% decline in eGFR, end stage kidney disease, or non-accidental death through Week 104 | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, KSA, Lithuania, Mexico, Netherlands, Norway, Poland, S Korea, Spain, Sweden Hungary Estonia Latvia, Taiwan, Turkey, UK, USA
Contacts
Public ContactEPS Corporation jRCT inquiry reception center
EPS Corporation
Outcome results
None listed