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Study of WAL0921 in Patients With Glomerular Kidney Diseases
Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements
About the study
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.
What is being tested
- WAL0921 (drug)
- Placebo (drug)
Sponsor: Walden Biosciences · Participants: 96 · Started: Jul 2, 2024
Contact the study team
- Michelle Skupien · Phone: 8573141961
Official record on ClinicalTrials.gov — NCT06466135
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.