Acthar for Treatment of Proteinuria in Diabetic Nephropathy Patients

What Was Tested

This registered phase 2 trial tested ACTH (Corticotropin).

It had six arms (groups): one (experimental), one (placebo comparator), one (experimental), one (placebo comparator) and one (experimental).

Repository Corticotropin Injection.

Placebo.

Repository Corticotropin Injection.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 34 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: Body mass index ≤ 45 kg/m2 at screening. Renal Target Disease Requirements:.

The full record lists 12 inclusion and 27 exclusion criteria; among the exclusions: therapies and/or medications:; history of prior sensitivity to acthar or other porcine protein products; planned treatment with live or live attenuated vaccines once enrolled in the study.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the ACTH (Corticotropin) group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received ACTH (Corticotropin).

Those kept unaware of assignments: participant and investigator.

It started in 2012-05 with completion listed for 2016-01.

It ran at 10 sites in United States (10).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12 (time frame: Visit 12 (Week 36)).

It also tracked 8 secondary outcomes, for example Percent Change in eGFR at Visit 17, Complete or Partial Remission of Proteinuria, Percent Change in eGFR Calculated Using Cystatin C, Percent Change From Baseline in eGFR by Visit, Percent Change From Baseline in Protein to Creatinine Ratio (PCR) and Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of ACTH (Corticotropin) in 34 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.