Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy

What Was Tested

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

Treatment with combination ACTHar gel and Tacrolimus therapy or ACTHar gel therapy alone in lowering urinary protein to creatinine (UP/Cr) ratios.

It had two arms (groups): ACTHar gel combined with Tacrolimus (active comparator) and ACTHar gel (active comparator).

ACTHar Gel units 2 times per week for 52 weeks.

The registry classes the interventions as drug.

Who Took Part

It was open to men only aged from 65 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Mesangial expansion with/without glomerular sclerosis diffuse sclerosis. Biopsy proven Fibrillary GN within 3 years of study randomization. Stable Maximum RAAS inhibition X 40 weeks prior to randomization Note: Maximum inhibition will be the discretion of the site PI. EGFR \> 25 mls/min. Blood pressure targeted to \< 140 at the time of randomization.

The full record lists 20 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, single-group and open-label.

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.

Nothing was hidden in this open-label ACTH (Corticotropin) study: the participants and staff both knew the treatment.

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

It started in 2019-01-12 with completion listed for 2024-09-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: change in UP/Cr ratio in patients with biopsy proven Fibrillary after treated with ACTHar gel alone OR in combination with oral Tacrolimus (time frame: 12 months).

It also tracked 2 secondary outcomes, for example relative change in UP/Cr and T that achieves complete, partial or clinical responses.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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