The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of povetacicept in participants with immunoglobulin A nephropathy (IgAN).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
605
Subcutaneous injection administration.
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Week 112
Percentage Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR)
Time frame: From Baseline through Week 104
Total Estimated Glomerular Filtration Rate (eGFR) Slope
Time frame: From Baseline through Week 104
Change from Baseline in Galactose-deficient immunoglobulin A1 (Gd-IgA1)
Time frame: From Baseline through Week 104
Percent Change from Baseline in Galactose-deficient immunoglobulin A1 (Gd-IgA1)
Time frame: From Baseline through Week 104
Proportion of Participants Achieving Clinical Remission
Clinical remission is defined as UPCR less than (\<)0.5 grams per gram (g/g), absence of hematuria, and eGFR decrease \<25 percentage (%) from baseline.
Time frame: From Baseline through Week 104
Proportion of Participants to Achieve Hematuria Resolution
Time frame: From Baseline through Week 104
Time to Kidney Disease Progression
Kidney disease progression is defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death
Time frame: From Baseline through Week 104
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