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Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Colorado Kidney and Vascular Care
Denver, Colorado, United States
D & H Tamarac Research Center
Tamarac, Florida, United States
Westmead Hospital
Westmead, New South Wales, Australia
Western Health Sunshine Hospital
St Albans, Victoria, Australia
Royal Derby Hospital
Derby, United Kingdom
College of Life Sciences, University of Leicester
Leicester, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Salford Royal NHS Foundation Trust
Salford, United Kingdom
Start Date
July 2, 2024
Primary Completion Date
October 1, 2025
Completion Date
March 1, 2026
Last Updated
April 6, 2025
96
ESTIMATED participants
WAL0921
DRUG
Placebo
DRUG
Lead Sponsor
Walden Biosciences
NCT05505500
NCT06441591
Data Source & Attribution
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