Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria

What Was Tested

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

Focal segmental glomerulosclerosis (FSGS) is a condition that harms the kidney "filters" that remove waste from the blood.

Proteins are supposed to stay in the blood.

Damaged "filters" let protein get into the kidney.

It had 1 arm (groups): Acthar Gel (other).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 63 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: Is male or non-pregnant, non-lactating female. Has primary FSGS, is nephrotic and did not achieve at least partial proteinuria response with prior therapy. Has been treated with an angiotensin converting enzyme inhibitor or receptor blocker (or have documented intolerance), for at least 4 weeks before screening. Has blood pressure no higher than 150/90 mmHg. Meets all other inclusion criteria detailed in the protocol.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: has hepatitis b or c, tuberculosis, or other contraindication listed on the united states (us) prescribing information for acthar; has received specific treatments at exclusionary time points per protocol; has been involved in a therapeutic drug/device trial (other than for fsgs) within 4 weeks before screening.

How the Study Was Run

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

Everyone knew when ACTH (Corticotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2016-10-10 with completion listed for 2020-08-27.

It ran at 47 sites in United States (21), Turkey (Türkiye) (8), Australia (7), Peru (4), Argentina (3) and Chile (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Adverse Events (time frame: within 56 weeks).

What This Means in Plain Language

Put simply, this is a phase 4 trial of ACTH (Corticotropin) in 63 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.