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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
605
Subcutaneous injection administration.
Placebo matched to Povetacicept subcutaneous injection administration.
Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36
Time frame: From Baseline at Week 36
Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104
Time frame: From Baseline Through Week 104
Change from Baseline in Serum Gd-IgA1 at Week 36
Time frame: From Baseline at Week 36
Proportion of Participants to Achieve Hematuria Resolution at Week 36 (Among Participants With Hematuria at Baseline)
Time frame: From Baseline at Week 36
Change From Baseline in eGFR at Week 104
Time frame: From Baseline at Week 104
Time to Kidney Disease Progression 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
Time frame: From Baseline Through Week 104
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Apogee Clinical Research, LLC
Huntsville, Alabama, United States
Arizona Kidney Disease and Hypertension Center - Thomas Office
Phoenix, Arizona, United States
Arizona Kidney Disease and Hypertension Center - Tuscon
Tucson, Arizona, United States
West Coast Kidney
Fremont, California, United States
The Medical Research Group, Inc. (FRENOVA)
Fresno, California, United States
CARE Institute - Carabello Kidney
Los Angeles, California, United States
Providence Medical Foundation - Orange
Orange, California, United States
National Nephrology Alliance Research
Riverside, California, United States
UC Davis Health
Sacramento, California, United States
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States
...and 308 more locations