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Evaluating WAL0921 for kidney diseases

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

PHASE2 · Walden Biosciences · NCT06466135

This study is testing a new drug called WAL0921 to see if it can help people with different types of kidney diseases feel better.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment96 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorWalden Biosciences (industry)
Locations50 sites (Los Angeles, California and 49 other locations)
Trial IDNCT06466135 on ClinicalTrials.gov

What this trial studies

This clinical trial is an adaptive, multi-center, randomized, double-blind, placebo-controlled study aimed at assessing the safety and efficacy of WAL0921 in patients with various glomerular kidney diseases, including diabetic nephropathy and rare conditions like focal segmental glomerulosclerosis. Participants will receive either the investigational drug or a placebo via intravenous infusion every two weeks for a total of seven infusions. The study will monitor participants for 24 weeks following their last infusion to evaluate the drug's pharmacokinetics and pharmacodynamics.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with specific glomerular kidney diseases and an eGFR of 30 mL/min/1.73 m2 or higher.

Not a fit: Patients who are currently pregnant, have a history of organ transplantation, or have acute kidney injury within the last six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve kidney function and reduce proteinuria in patients with glomerular kidney diseases.

How similar studies have performed: Other studies have shown promise in treating similar kidney conditions, but the specific approach with WAL0921 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Los Angeles, California and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Diabetic Nephropathies, Primary Focal Segmental Glomerulosclerosis, Minimal Change Disease, Primary Immunoglobulin A Nephropathy, Primary Membranous Nephropathy, DN, FSGS, TR-MCD

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.