A Study of Acthar Gel Alone or With Tacrolimus to Reduce Proteinuria in Fibrillary Glomerulopathy Patients

What Was Tested

This registered phase 4 trial tested ACTH (Corticotropin).

It had two arms (groups): Treatment with Acthar gel (active comparator) and Treatment with combination Acthar gel and Tacrolimus therapy (active comparator).

The registry classes the interventions as drug.

More on the Plan

This study will be a multi-center, prospective, randomized, open-labeled intervention trial of 34 patients randomized to 52 weeks of ACTHar gel alone or Acthar gel plus oral Tacrolimus.

Who Took Part

Enrollment: 34 planned participants were the target.

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: Male/Female age \> 18. Biopsy proven Fibrillary glomerulonephritis within 3 years of study randomization. Stable Maximum Renin-Angiotensin-Aldosterone System inhibition times 4 weeks prior to randomization Note: Maximum RAAS inhibition will be left to the discretion of the site Principal Investigator. Estimated Glomerular Filtration Rate \> 25 mls/min calculate by the Chronic Kidney Disease-EPI formula. Blood pressure targeted to \< 140/90 at the time of randomization.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: patients with mgus and history of myeloma will not be eligible; patients with active viral production of either hepatitis b or c as evidence by historical polymerase chain reaction test positive for active viral shedding; HIV seropositivity.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got ACTH (Corticotropin) and who got the comparison, which limits bias.

The ACTH (Corticotropin) group and the comparison group ran side by side rather than switching.

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

It started in 2019-03-14 with completion listed for 2023-10-27.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The change in UP/CR ratio with treatment of Acthar gel [amount hidden] subcutaneous 2 times a week alone. The change in UP/CR ratio with treatment of Acthar gel [amount hidden] subcutaneous 2 times a week in combination with oral Tacrolimus.

It also tracked 4 secondary outcomes, for example The relative change in protein/creatinine ratio at 24 months, Percentage of patients complete or partial response and The change in Estimated Glomerular Filtration Rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 34 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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