Safety and Efficacy of Acthar Gel in an Outpatient Dialysis Population

What Was Tested

In this phase 1 trial, researchers set out to test ACTH (Corticotropin).

This will be a prospective observational study of Acthar Gel in Non-Diabetic Hemodialysis \[NDHD\] patients receiving dialysis for ≤ 2 years.

It had two arms (groups): one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

There are limited published reports documenting the clinical response (creatinine, proteinuria, serum albumin and cholesterol) to ACTHAR therapy in a non-diabetic hemodialysis population.

Strength deficits are well documented in those with End Stage Renal Disease \[ESRD\] (Cheema 2010, Yoda 2012).

There are several reports documenting an association between strength and gait deficits and other measures of physical performance in persons with ESRD (Bohannon 1994, Fitts 1997, Segura-Orti 2011).

It is well known that measures of physical performance may predict risk for fall and hospitalization in older individuals (Guralnik JM, 2000).

Who Took Part

9 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Inclusion criteria will be individuals requiring dialysis for treatment of ESRD who have had poor response to immunosuppressive strategies. Adults age 18-80.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: receiving hemodialysis for \> 5 years; diabetic, less than 18 years of age; are pregnant.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on ACTH (Corticotropin), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2015-03 with completion listed for 2016-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Renal Function (time frame: 6 months).

It also tracked 22 secondary outcomes, for example Hyperparathyroidism, Anemia, Inflammatory blood markers, Vitamin D uptake, Hypercalcemia and Phosphate.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of ACTH (Corticotropin) in 9 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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