This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and proteinuria, including diabetic nephropathy and rare glomerular kidney diseases (primary focal segmental glomerulosclerosis \[FSGS\], treatment-resistant minimal change disease \[TR MCD\], primary immunoglobulin A nephropathy \[IgAN\], and primary membranous nephropathy \[PMN\]). Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions. All subjects will be followed for 24 weeks after their last infusion.
Adults, age 18-75 years
Diagnosis of one of the following glomerular kidney diseases: diabetic nephropathy; primary focal segmental glomerulosclerosis; treatment resistant-minimal change disease; primary IgA nephropathy; primary membranous nephropathy
eGFR greater than or equal to 30 mL/min/1.73 m2
Currently pregnant or planning to become pregnant
History of organ transplantation
History of alcohol or substance use disorder
Acute dialysis or acute kidney injury within 6 months of Screening
Parallel
WAL0921
DrugInvestigational drug WAL0921 Participants receive an intravenous infusion of WAL0921 investigational drug once every 2 weeks for 7 total infusions.
Placebo
DrugPlacebo product Participants receive an intravenous infusion of placebo once every 2 weeks for 7 total infusions.
Incidence of treatment emergent adverse events
Change in albuminuria
Percent change in urine albumin-creatinine ratio (UACR)
Change in proteinuria
Percent change in urine protein-creatinine ratio (UPCR)
Change in estimated glomerular filtration rate
Percent change in estimated glomerular filtration rate (eGFR)
Change in rate of change in eGFR
Slope of eGFR
Click on the lead sponsor to view all of their trials.