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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Colorado Kidney and Vascular Care
Denver, Colorado, United States
RECRUITINGD & H Tamarac Research Center
Tamarac, Florida, United States
RECRUITINGWestmead Hospital
Westmead, New South Wales, Australia
ACTIVE_NOT_RECRUITINGWestern Health Sunshine Hospital
St Albans, Victoria, Australia
ACTIVE_NOT_RECRUITINGRoyal Derby Hospital
Derby, United Kingdom
NOT_YET_RECRUITINGCollege of Life Sciences, University of Leicester
Leicester, United Kingdom
NOT_YET_RECRUITINGBarts Health NHS Trust
London, United Kingdom
NOT_YET_RECRUITINGManchester University NHS Foundation Trust
Manchester, United Kingdom
NOT_YET_RECRUITINGSalford Royal NHS Foundation Trust
Salford, United Kingdom
NOT_YET_RECRUITINGIncidence of treatment emergent adverse events
Time frame: Baseline to Week 36
Change in albuminuria
Percent change in urine albumin-creatinine ratio (UACR)
Time frame: Baseline up to Week 24
Change in proteinuria
Percent change in urine protein-creatinine ratio (UPCR)
Time frame: Baseline up to Week 24
Change in estimated glomerular filtration rate
Percent change in estimated glomerular filtration rate (eGFR)
Time frame: Baseline up to Week 24
Change in rate of change in eGFR
Slope of eGFR
Time frame: Baseline up to Week 24
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