Study of WAL0921 for Glomerular Kidney Diseases

This study is testing an investigational drug called WAL0921 for people with certain kidney diseases, including diabetic nephropathy, primary focal segmental glomerulosclerosis (FSGS), minimal change disease, primary IgA nephropathy, and primary membranous nephropathy. You might be able to join if you are an adult between 18 and 75 years old and have one of these conditions with an eGFR (a measure of kidney function) of 30 mL/min or higher. Participants will receive either WAL0921 or a placebo (an inactive substance) through an IV every two weeks for a total of seven infusions. The main goal is to see how safe WAL0921 is by tracking any side effects up to 36 weeks.

Study design
This is a randomized, double-blind study, meaning participants are randomly assigned to receive either WAL0921 or a placebo, and neither you nor your doctors will know which you are receiving. The study plans to enroll 96 participants.
What's involved
You would receive an intravenous infusion of either WAL0921 or placebo once every two weeks for a total of seven infusions. You will then be followed for 24 weeks after your last infusion.
Compensation
Not stated in the trial record.
Follow-up
All subjects will be followed for 24 weeks after their last infusion.

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NCT06466135

Study of WAL0921 in Patients With Glomerular Kidney Diseases

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Walden Biosciences
~96 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:WAL0921Placebo

At a glance

Recruiting sites
25 of 50 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment emergent adverse events
Measured over Baseline to Week 36
Diabetic Nephropathies
Primary Focal Segmental Glomerulosclerosis
Minimal Change Disease
Primary Immunoglobulin A Nephropathy
Primary Membranous Nephropathy
50 sites across 26 states
South Korea6
Sri Lanka5
United Kingdom5
Texas3
Kuala Lumpur3
Gujarat2
Karnataka2
Maharashtra2
  • Rekha Abichandani, MD · STUDY_DIRECTOR · Walden Biosciences

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Eligibility criteria

Inclusion

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

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
  • Incidence of treatment emergent adverse eventsBaseline to Week 36