Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH

What Was Tested

The trial (phase 4) is built around ACTH (Corticotropin).

FSGS is an immunologic disorder wherein circulating immune proteins cause damage to the kidneys and progressive injury and scarring.

The investigators believe that ACTH therapy (H.P.

It had 1 arm (groups): No arms (experimental).

There are no arms to this study. All patients receive drug (H.P. Acthar Gel).

The registry classes the interventions as drug.

More on the Plan

The investigators will recruit 18-20 patients to complete this study, over 2 years.

ACTH therapy: Patients will receive H.P.

All patients will be treated to goal BP of \<140/90mmHg with all patients treated with ACEi or ARB therapy as tolerated.

H2 receptor blockade or proton pump inhibitor therapy will also be offered all patients.

Who Took Part

15 actual participants took part.

It was open to people of any sex aged from 16 years up to 65 years.

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

Examples of who could join: 1\. Biopsy proven FSGS. 2\. Ability to consent and complete study evaluations. 4\. No contraindications to treatment with corticosteroids or ACTH.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: 1\. known secondary cause of fsgs; 2\. receiving active immune therapy (within 90 days); 3\. pregnancy.

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 2009-09 with completion listed for 2014-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 24 Hour Proteinuria (time frame: Baseline - Month 6). Serum Creatinine (time frame: Baseline - Month 6). Protein/Creatinine Ratio (time frame: Baseline - Month 6).

It also tracked 6 secondary outcomes, for example eGFR, Weight, Systolic Blood Pressure, Diastolic Blood Pressure, Glucose and Total Cholesterol.

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.