NCT06466135

Study of WAL0921 in Patients With Glomerular Kidney Diseases

Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Walden Biosciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetic Nephropathies
• Primary Focal Segmental Glomerulosclerosis
• Minimal Change Disease
• Primary Immunoglobulin A Nephropathy
• Primary Membranous Nephropathy

Interventions

Type	Name	Description
DRUG	WAL0921	Investigational drug WAL0921 Participants receive an intravenous infusion of WAL0921 investigational drug once every 2 weeks for 7 total infusions.
DRUG	Placebo	Placebo product Participants receive an intravenous infusion of placebo once every 2 weeks for 7 total infusions.

Timeline

• Start date: 2024-07-02
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2024-06-20
• Last updated: 2026-04-02

Locations

50 sites across 7 countries: United States, Australia, India, Malaysia, South Korea, Sri Lanka, United Kingdom

Regulatory

• FDA-regulated drug study