Table of contents
Trial overview
The trial data provided include one study that listed Aminohippuric Acid as part of the intervention plan.[1] The study was called the MONET study and focused on rescue therapy in patients with membranous nephropathy who had failed anti-CD20 target therapy.[1]
This was an interventional study, which means researchers gave a treatment and then measured the results.[1] The study status was completed, so the planned trial work has already ended.[1]
Who was studied
The trial studied people with membranous nephropathy, a kidney disease that can cause heavy protein loss in the urine.[1] The brief summary says the study focused on patients with nephrotic-range proteinuria, which means a very large amount of protein in the urine.[1]
The target population also included patients who were resistant to or dependent on anti-CD20 antibodies.[1] In simple terms, these were people whose earlier treatment did not work well enough or who still needed that kind of therapy.[1]
What was measured
The main endpoint was the reduction in 24-hour urinary protein excretion at 12 months after the first MOR202 administration compared with baseline.[1] Baseline means the starting point before treatment began.[1]
The study also measured a composite endpoint, which is a combined result made from more than one outcome.[1] In this trial, the composite endpoint included complete remission or partial remission of nephrotic syndrome at 12 months from the first infusion.[1]
Complete remission was defined in the trial as 24-hour urinary protein excretion below 0.3 g or a urinary protein to creatinine ratio below 300 mg/g, with serum albumin above 3.5 g/dL.[1] Partial remission was defined as 24-hour urinary protein excretion below 3.5 g or a urinary protein to creatinine ratio below 3500 mg/g, with at least a 50% reduction compared with baseline.[1]
Trial phase and status
The trial was in Phase 2.[1] Phase 2 studies usually look at whether a treatment may help in a specific disease and continue to collect clinical outcome data.[1]
The study status was completed, and the enrollment was 10 participants.[1] This means the trial was small and focused on a specific group of patients.[1]
Key trial details
Trial ID: NCT04893096.[1]
Title: Rescue Therapy with the Human Anti-CD38 Antibody MOR202 (felzartamab) in Patients with Membranous Nephropathy who Failed Anti-CD20 Target Therapy (MONET study).[1]
Condition studied: Membranous nephropathy.[1]
Study type: Interventional.[1]
Phase: Phase 2.[1]
Status: Completed.[1]
Enrollment: 10 participants.[1]
The intervention list in the trial data included Aminohippuric Acid, OMNIPAQUE, and felzartamab.[1] The provided trial record does not explain the role of Aminohippuric Acid separately from the rest of the study interventions.[1]
