In short
Clinical trials investigating Aminohippuric Acid are studying patients with membranous nephropathy. In the trial data provided, Aminohippuric Acid appears as part of an interventional study that also includes other study drugs. The main aim is to assess changes in protein in the urine and remission of nephrotic syndrome.
Key points
- Aminohippuric Acid is listed in one completed Phase 2 clinical trial for membranous nephropathy. The study involved patients with nephrotic-range proteinuria who were resistant to or dependent on anti-CD20 treatment. Researchers measured whether treatment could lower 24-hour urinary protein excretion and improve remission of nephrotic syndrome. The trial also looked at complete remission and partial remission at 12 months after the first treatment. Only 10 patients were enrolled in the study.
Trial overview
The trial data provided include one study that listed Aminohippuric Acid as part of the intervention plan. The study was called the MONET study and focused on rescue therapy in patients with membranous nephropathy who had failed anti-CD20 target therapy.
This was an interventional study, which means researchers gave a treatment and then measured the results. The study status was completed, so the planned trial work has already ended.
Who was studied
The trial studied people with membranous nephropathy, a kidney disease that can cause heavy protein loss in the urine. The brief summary says the study focused on patients with nephrotic-range proteinuria, which means a very large amount of protein in the urine.
The target population also included patients who were resistant to or dependent on anti-CD20 antibodies. In simple terms, these were people whose earlier treatment did not work well enough or who still needed that kind of therapy.
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. Baseline means the starting point before treatment began.
The study also measured a composite endpoint, which is a combined result made from more than one outcome. In this trial, the composite endpoint included complete remission or partial remission of nephrotic syndrome at 12 months from the first infusion.
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. 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.
Trial phase and status
The trial was in Phase 2. Phase 2 studies usually look at whether a treatment may help in a specific disease and continue to collect clinical outcome data.
The study status was completed, and the enrollment was 10 participants. This means the trial was small and focused on a specific group of patients.
Key trial details
- Trial ID: NCT04893096.
- Title: Rescue Therapy with the Human Anti-CD38 Antibody MOR202 (felzartamab) in Patients with Membranous Nephropathy who Failed Anti-CD20 Target Therapy (MONET study).
- Condition studied: Membranous nephropathy.
- Study type: Interventional.
- Phase: Phase 2.
- Status: Completed.
- Enrollment: 10 participants.
The intervention list in the trial data included Aminohippuric Acid, OMNIPAQUE, and felzartamab. The provided trial record does not explain the role of Aminohippuric Acid separately from the rest of the study interventions.