Study of WAL0921 in Patients With Glomerular Kidney Diseases

Phase 2

Recruiting

• Conditions: Diabetic Nephropathies; Primary Immunoglobulin A Nephropathy; Primary Membranous Nephropathy; Minimal Change Disease; Primary Focal Segmental Glomerulosclerosis
• Interventions: Drug: Placebo; Drug: WAL0921

• Registration Number: NCT06466135
• Lead Sponsor: Walden Biosciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-18
• Study First Posted: 2024-06-20
• Study Start: 2024-07-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-10
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intravenous infusion of normal saline
WAL0921	WAL0921	Intravenous infusion of investigational drug WAL0921

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events	Baseline to Week 36

Secondary Outcome Measures

Name	Time	Method
Change in albuminuria	Baseline up to Week 24	Percent change in urine albumin-creatinine ratio (UACR)
Change in proteinuria	Baseline up to Week 24	Percent change in urine protein-creatinine ratio (UPCR)
Change in estimated glomerular filtration rate	Baseline up to Week 24	Percent change in estimated glomerular filtration rate (eGFR)
Change in rate of change in eGFR	Baseline up to Week 24	Slope of eGFR

Trial Locations

Locations (9)

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

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