Glomerulonephritis rapidly progressive Trials in Disease

Study on the Safety and Tolerability of Lixudebart and Rituximab for Patients with Rapidly Progressive Glomerulonephritis Due to ANCA-Associated Vasculitis

This clinical trial focuses on testing a new treatment for patients with rapidly progressive glomerulonephritis caused by a condition called ANCA-associated vasculitis. The main goal is to evaluate whether the investigational drug ALE.F02 (also known as lixudebart) is safe and well-tolerated when given to patients with this serious kidney condition.

Who can participate:

• Adults aged 18 years or older
• Patients weighing 130 kg or less
• Individuals with a Clinical Frailty Scale score of less than 7
• Those newly diagnosed with rapidly progressive glomerulonephritis within the last 45 days, confirmed by reduced kidney function and evidence of protein or blood in the urine
• Patients suspected of having RPGN due to ANCA-associated vasculitis, based on positive ANCA antibody tests
• Willingness to undergo or have recently had a kidney biopsy within the last 45 days
• Female participants must not be pregnant or breastfeeding and must use effective birth control
• Male participants must agree to use contraception during the study and for 90 days afterward

Who cannot participate:

• Patients with other types of kidney disease that are not rapidly progressive glomerulonephritis
• Individuals outside the specified age range
• People who cannot give informed consent or are considered vulnerable populations requiring extra protection

What the study involves:

The trial uses ALE.F02, an investigational medication administered through a continuous intravenous infusion directly into the bloodstream. This drug belongs to a class of medications called immunosuppressive agents, which work to reduce the body's immune response and decrease inflammation that damages the kidneys. The treatment may also involve other medications such as rituximab, a monoclonal antibody, and cyclophosphamide.

Participants will receive either ALE.F02 or a placebo over a treatment period lasting up to 24 weeks. Throughout the study, patients will have regular check-ups including blood tests, urine tests, and other evaluations to monitor kidney function, protein levels in urine, overall health, and any side effects. The study aims to determine whether ALE.F02 can help protect the kidneys and improve kidney function in patients with this challenging condition.

The study follows a structured process: after providing informed consent and undergoing initial assessments to confirm eligibility, participants receive the study medication while being closely monitored. Regular follow-up appointments track progress and side effects, with a final comprehensive assessment conducted at the end of the treatment period to evaluate the overall impact on the patient's condition.