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Aminohippuric Acid

Clinical trials with Aminohippuric Acid are being studied in patients with membranous nephropathy. The trial data focus on treatment effects such as protein loss in urine and remission of nephrotic syndrome. The target population includes adults with disease that did not respond well to prior anti-CD20 treatment.

Table of contents

Trial overview

The provided trial for Aminohippuric Acid was an interventional study in patients with membranous nephropathy.[1] The study was called the MONET study and was designed to evaluate rescue therapy in people who had failed anti-CD20 target therapy.[1]

The brief study summary says the goal was to evaluate whether the treatment could reduce or stop urinary protein loss in patients with nephrotic-range proteinuria.[1]

Who was studied

The target population was patients with membranous nephropathy who had nephrotic-range proteinuria.[1] The trial also focused on people who were resistant to or dependent on anti-CD20 antibodies, which means earlier treatment had not worked well enough or was still needed.[1]

This was a small study with 10 enrolled participants.[1] That size suggests the trial was meant to get an early look at treatment effect in a limited group.[1]

What was measured

The main outcome was the reduction in 24-hour urinary protein excretion at 12 months after the first administration compared with baseline.[1] 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 sign of improvement.[1] In this trial, the combined endpoint included complete remission or partial remission of nephrotic syndrome at 12 months.[1]

Complete remission in the trial meant 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 meant 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 from baseline.[1]

Trial phase and size

The study was a Phase 2 trial.[1] Phase 2 trials usually look more closely at whether a treatment seems to work in the target disease, while also collecting more information in a small group of patients.

The study status was Completed.[1] This means the trial has finished and the results can be reviewed from the recorded data.

Key points for patients

  • The trial studied membranous nephropathy, a kidney disease that can cause heavy protein loss in urine.[1]

  • It focused on people whose disease had not responded well to anti-CD20 target therapy or who still depended on it.[1]

  • Researchers mainly looked at protein loss in urine and remission of nephrotic syndrome after 12 months.[1]

  • The trial was small, with 10 participants, and it was a Phase 2 study.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04893096 Phase 2 Membranous nephropathy Completed 10

FAQ

  • What are clinical trials with Aminohippuric Acid studying? The trial data study whether Aminohippuric Acid is linked to changes in urinary protein loss and remission in membranous nephropathy. The main goal is to see if the treatment can reduce nephrotic-range proteinuria.
  • Who was the target population in the trial? The trial focused on patients with membranous nephropathy and nephrotic-range proteinuria. It included people who were resistant to or dependent on anti-CD20 therapy.
  • What phase was the trial? The study was a Phase 2 trial. This means it was designed to look at treatment effects in a small group of patients.
  • What outcomes were measured? The main outcomes were reduction in 24-hour urinary protein excretion and remission of nephrotic syndrome. The study also looked at complete remission and partial remission at 12 months.
  • How many participants were enrolled? The trial enrolled 10 participants. This small number fits the early testing stage of a Phase 2 study.

Igangværende kliniske forsøg for Aminohippuric Acid

  • Afprøvning af MOR202 behandling hos patienter med membranøs nefropati, hvor tidligere behandling ikke har virket

    Rekrutterer ikke

    1 1 1
    Undersøgte lægemidler:
    Italien

Ordliste

  • Membranous nephropathy: A kidney disease that can cause large amounts of protein to leak into the urine.
  • Nephrotic-range proteinuria: A very high level of protein in the urine, which can be a sign of severe kidney damage.
  • Anti-CD20 therapy: A treatment approach that targets CD20-positive cells; in this trial, patients had not responded well to it or still needed it.
  • Phase 2: A trial phase that usually studies whether a treatment seems to work and continues to monitor safety in a small group.
  • Interventional study: A study where participants receive a treatment so researchers can measure its effects.
  • 24-hour urinary protein excretion: The amount of protein found in urine collected over 24 hours.
  • Complete remission: A strong treatment response, with very low protein loss and normal or near-normal blood albumin in this study.
  • Partial remission: An improvement that does not fully normalize the disease, but shows a major drop in protein loss.
  • Serum albumin: A protein in the blood that can become low when too much protein is lost in the urine.
  • Nephrotic syndrome: A group of signs caused by kidney disease, including heavy protein loss in urine.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/afprovning-af-mor202-behandling-hos-patienter-med-membranos-nefropati-hvor-tidligere-behandling-ikke-har-virket/