Treatment of Resistant Nephrotic Syndrome With ACTH Gel (ACTHAR)

What Was Tested

In this phase 4 trial, researchers set out to test ACTH (Corticotropin).

It is caused by a variety of diseases and underlying disorders that damage the kidneys, resulting in excessive excretion of protein in the urine.

These diseases damage the glomeruli, which are small blood vessels that filter wastes and excess water from the blood and pass them into the bladder as urine.

It had 1 arm (groups): Acthar gel (experimental).

The registry classes the interventions as drug.

More on the Plan

The nephrotic syndrome is characterized by heavy proteinuria, edema, hyperlipidemia, and a thrombotic tendency.

Membranous nephropathy, focal segmental glomerulosclerosis, resistant minimal change disease, and Immunoglobulin A (IgA) nephropathy (also known as Berger's disease) are the common forms of idiopathic nephrotic syndrome in adults.

All such immunosuppressives have multiple potential serious side effects.

Some patients either relapse after remissions of their proteinuria or are resistant to immunosuppressive therapy.

Who Took Part

15 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.

Examples of who could join: Adult nephrotic patients, at least 18 years of age. Willing and able to sign informed consent. Patients of childbearing age must agree to use birth control.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: patients under 18 years of age; patients unable to sign informed consent; patients having received rituximab or another monoclonal antibody within 6 months of the trial.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the ACTH (Corticotropin) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-12 with completion listed for 2011-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Sustained Remissions up to 1 Year After Discontinuing Therapy.

What This Means in Plain Language

Put simply, this is a phase 4 trial of ACTH (Corticotropin) in 15 people.

Its size is small, so on its own it can only give an early look.

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.