Acthar for Treatment of Proteinuria in Membranous Nephropathy Patients

What Was Tested

This registered phase 4 trial tested ACTH (Corticotropin).

Approximately sixty (60) subjects will be randomized in this double-blind, parallel-group, placebo-controlled, multicenter study comparing Acthar and Placebo administered 2 times per week for a 24-week treatment period followed by a 24-week observation period.

The primary objective of this study is to assess the proportion of treatment-resistant subjects (defined as subjects who either have had no response or have suffered a relapse after achieving a partial response to their most recent standard treatment regimen) who have a complete or partial remission of proteinuria in nephrotic syndrome due to idiopathic membranous nephropathy after 24 weeks of treatment.

The registry classes the interventions as drug.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 0 inclusion and 32 exclusion criteria; among the exclusions: male or female subjects ≥18 years of age, at screening visit 1:; body mass index ≤40 kg/m2, at screening visit 1;; renal target disease requirements:.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this ACTH (Corticotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The ACTH (Corticotropin) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on ACTH (Corticotropin), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2011-08 with completion listed for 2016-11-21.

It ran at 28 sites in United States (14), Turkey (Türkiye) (9), Chile (2), Mexico (2) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants With Complete or Partial Remission in Proteinuria at 24 Weeks (time frame: At Visit 8 (Week 24)).

It also tracked 1 secondary outcome, for example Percentage of Participants With Sustained Remission.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 60 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the ACTH (Corticotropin) compound page, all human trials.