Immunoglobulin A Nephropathy
Conditions
Keywords
IgAN, Berger's disease, glomerulonephritis, IgA nephropathy, ALPN-303, BAFF, BLyS, APRIL
Brief summary
The purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal function.
Interventions
DRUGPovetacicept
Subcutaneous injection administration.
DRUGPlacebo (matched to Povetacicept)
Placebo matched to Povetacicept subcutaneous injection administration.
Sponsors
Alpine Immune Sciences Inc, A Subsidiary of Vertex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosed IgAN, with biopsy confirmation * 24-hr proteinuria excretion ≥1.0 g/day or 24-hour uPCR ≥0.75 g/g * Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2 * Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification Key
Exclusion criteria
* 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 * Rapidly progressive glomerulonephritis with eGFR reduction \>50% within 12 weeks of the start of screening Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104 | From Baseline Through Week 104 |
| Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36 | From Baseline at Week 36 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Serum Gd-IgA1 at Week 36 | From Baseline at Week 36 | — |
| Proportion of Participants to Achieve Hematuria Resolution at Week 36 (Among Participants With Hematuria at Baseline) | From Baseline at Week 36 | — |
| Change From Baseline in eGFR at Week 104 | From Baseline at Week 104 | — |
| Time to Kidney Disease Progression Through Week 104 | From Baseline Through Week 104 | Kidney disease progression defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Saudi Arabia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed