Study of ALE.F02 Infusions Added to Standard Therapy to Preserve Kidney Function in ANCA-Associated Vasculitis with Rapidly Progressive Glomerulonephritis

What this Trial Is About

Researchers are investigating a new drug called ALE.F02 to see if it can help protect and preserve kidney function in people with antineutrophil cytoplasmic antibody ANCA associated vasculitis AAV, an autoimmune disease where the immune system attacks small blood vessels, often affecting the kidneys. The study aims to determine if ALE.F02 is safe, well tolerated, and effective when added to standard therapy for kidney inflammation caused by AAV. Participants will be assigned to one of four groups standard treatment plus ALE.F02 at low, high, or maximum doses, or standard treatment plus placebo infusions. The treatment phase lasts 24 weeks, during which participants receive 13 infusions of ALE.F02 or placebo alongside their usual therapy for AAV-related kidney inflammation. The study includes monitoring of physical health, blood and urine tests, and lung CT scans to assess vasculitis involvement. Throughout the study, participants will undergo physical exams, blood and urine sample collections to monitor kidney function, detect antibodies against the study drug, and measure biomarkers indicating disease activity. Lung scans are performed at the start and at Week 24 if lung involvement is detected. Researchers will evaluate safety and tolerability of ALE.F02 and measure changes in kidney function and protein levels over time. The study may continue up to one year to monitor outcomes and safety.

Rescue of Nephrons With ALE.F02 (RENAL-F02)