Adrenocorticotropic Hormone in Membranous Nephropathy

What Was Tested

This registered phase 4 trial tested ACTH (Corticotropin).

The purpose of this study is to evaluate the effect of adrenocorticotropic hormone (ACTH, Acthar) on the loss of proteins in the urine (proteinuria) in patients with membranous nephropathy.

Acthar is a hormone that stimulates steroid production from small glands above the kidneys.

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

The registry classes the interventions as drug.

More on the Plan

Patients with membranous nephropathy and nephrotic syndrome will be treated with ACTH for 6 months.

Proteinuria remission at 12 months will be the primary endpoint.

Different biomarkers including anti-PLA2R autoantibodies, circulating regulatory T cells, and autoreactive memory B cells will be serially measured to identify predictors of response to therapy.

Who Took Part

5 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age 18 to 70 years. Free of immunosuppression for at least 3 months. Capability of understanding the purpose of the study. Written informed consent.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: kidney transplant; secondary mn (defined on the basis of clinical criteria); type 1 or type 2 diabetes mellitus (prior diagnosis of gestational diabetes mellitus is not an exclusion).

How the Study Was Run

Design: single-group and open-label.

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 2018-03-19 with completion listed for 2020-12-16.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Proteinuria (time frame: baseline and 12 months).

It also tracked 6 secondary outcomes, for example Number of Participants With Complete or Partial Remission, Change in Serum Albumin, Estimated Glomerular Filtration Rate (GFR), Number of Anti-PLA2R Memory B Cells, Anti-PLA2R Antibodies Levels and Change in CD4+CD25+CD127low T Regulatory Cells/CD4+ T Cell Ratio.

What This Means in Plain Language

Put simply, this is a phase 4 trial of ACTH (Corticotropin) in 5 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.