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Study of WAL0921 in Patients With Glomerular Kidney Diseases

NCT06466135 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-04-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Walden Biosciences

    lead INDUSTRY

Principal Investigators

  • Andrew Blair, MD · Walden Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-02
Primary Completion
2027-03-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • India
  • Malaysia
  • South Korea
  • Sri Lanka
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06466135 on ClinicalTrials.gov