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Phase 2
Age: 18Years - 75Years
All Genders
ID06466135

Study of WAL0921 Treatment in Adults With Glomerular Kidney Diseases and Proteinuria Including Diabetic Nephropathy and Rare Kidney Conditions Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial

Led by Walden Biosciences · Updated on 2026-08-03

96

Participants Needed

50

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety, effectiveness, and how the body processes the investigational drug WAL0921 in adults with various glomerular kidney diseases and proteinuria. These include diabetic nephropathy and rare conditions such as primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary immunoglobulin A nephropathy, and primary membranous nephropathy. This is a Phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers to evaluate WAL0921 compared to a placebo. Participants will be randomly assigned to receive either the investigational drug WAL0921 or a placebo through an intravenous infusion every two weeks for a total of seven infusions. The study includes a treatment period followed by a 24-week follow-up after the last infusion to monitor participants. The treatments are given in parallel groups to compare their effects and safety. During the study, participants will undergo regular assessments including monitoring for adverse events from the start through Week 36. Researchers will also measure changes in albuminuria, proteinuria, and kidney function markers such as estimated glomerular filtration rate over 24 weeks. These evaluations help determine how the drug affects kidney disease markers and overall safety. The total participation time includes treatment and follow-up periods lasting several months.

CONDITIONS

Brief Title

Study of WAL0921 in Patients With Glomerular Kidney Diseases

Research Team

M

Michelle Skupien

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