Study of Rituximab Combined with Cyclosporine to Treat Idiopathic Membranous Nephropathy Evaluating Safety and Effectiveness in Adults with Nephrotic Syndrome

What this Trial Is About

Membranous nephropathy is a kidney condition where damage to the small blood vessels causes leakage of proteins into the urine, leading to low blood protein levels, high cholesterol, and leg swelling. About 25% of patients improve without treatment, but persistent cases can cause kidney function loss, heart and blood vessel problems, and blood clots. This research evaluates the safety and effectiveness of combining two immunosuppressive drugs, rituximab and cyclosporine, to treat this condition by targeting immune system cells involved in kidney damage. Participants will first undergo a run-in period up to 2 months, taking blood pressure medication and avoiding other immunosuppressants. Then, they will receive a six-month course of cyclosporine tablets twice daily and four intravenous rituximab infusionstwo doses given two weeks apart, followed by another two doses six months later, depending on blood test results. After six months, the cyclosporine dose will be gradually reduced and stopped. This combination therapy is being studied because it may better control immune activity than either drug alone. Throughout the study, participants will visit the clinical center for evaluations, including frequent blood and urine tests to monitor treatment effects and side effects. Researchers will assess safety by tracking adverse events and measure treatment success by the reduction of proteinuria and the number of complete or partial remissions over 6 to 24 months. The total study duration includes follow-up visits up to two years to evaluate long-term outcomes and remission durability.

Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy