Study of WAL0921 in Patients With Glomerular Kidney Diseases

Launched by WALDEN BIOSCIENCES · Jun 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called WAL0921 for patients with certain types of kidney diseases, specifically those that affect the filtering units of the kidneys, known as glomeruli. These conditions include diabetic nephropathy, primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary immunoglobulin A nephropathy, and primary membranous nephropathy. The goal is to determine if WAL0921 is safe and effective at reducing protein levels in the urine, which is a sign of kidney problems.

To participate in this trial, individuals must be adults aged 18 to 65 years and have a confirmed diagnosis of one of the specified kidney diseases. They should also have a certain level of kidney function, as measured by a test called eGFR. Participants will receive either the study drug or a placebo (a substance with no active treatment) through an intravenous infusion every two weeks, for a total of seven infusions. After the treatment period, they will be monitored for 24 weeks to see how they respond. It's important to note that pregnant individuals, those with a history of organ transplantation, and those with certain other medical issues will not be eligible for this study.

Gender

ALL

Eligibility 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