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WAL0921 for Kidney Disease

Phase 2
Recruiting
Research Sponsored by Walden Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 24

Summary

This trial is testing a new drug called WAL0921 in people with kidney disease and protein in their urine. The study will involve multiple medical centers and will look at the safety, effectiveness, how the

Who is the study for?
Adults aged 18-65 with certain kidney diseases (like diabetic nephropathy, primary FSGS, resistant minimal change disease, IgA nephropathy, or membranous nephropathy) and a minimum eGFR of 30 mL/min/1.73 m2 can join this study.
What is being tested?
The trial is testing WAL0921 against a placebo in patients with glomerular kidney diseases. Participants will receive the drug or placebo via IV every two weeks for seven doses and be monitored for six months after the last dose.
What are the potential side effects?
Possible side effects are not detailed here but typically include reactions at the infusion site, potential allergic responses to the drug components, and any impacts on kidney function or other organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a specific kidney disease.
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My kidney function is normal or mildly reduced.
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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in albuminuria
Change in estimated glomerular filtration rate
Change in proteinuria
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: WAL0921Experimental Treatment1 Intervention
Intravenous infusion of investigational drug WAL0921
Group II: PlaceboPlacebo Group1 Intervention
Intravenous infusion of normal saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
WAL0921
2023
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Walden BiosciencesLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Andrew Blair, MDStudy DirectorWalden Biosciences
1 Previous Clinical Trials
40 Total Patients Enrolled
~64 spots leftby Oct 2025
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