Adrenocorticotropic Hormone (ACTH) Treatment of Nephrotic Range Proteinuria in Diabetic Nephropathy (NRDN)

What Was Tested

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

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

The registry classes the interventions as drug.

More on the Plan

Previous studies investigating the effect of diabetes and insulin therapy on ACTH levels have given mixed results.

It is therefore unclear how podocytes in patients with diabetic nephropathy could become functionally deficient in ACTH.

Moreover, TGF-b is able block an ACTH-induced stimulation of melanocortin receptors.

This intriguing link between TGF-b and ACTH signaling raises the question of whether impaired signaling of ACTH in the glomerulus leads to podocyte dysfunction, accelerated detachment and ultimately podocyte apoptosis.

Who Took Part

The registry lists 15 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: Age \> 18 and \< 80. Type I or Type II Diabetes Mellitus. Stable ACE or ARB therapy for 4 weeks prior to study enrollment.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: age \<18 or \>80; egfr \< 20 mls/min by mdrd formula or egfr by (cockoff-gault 20 mls/min); pregnant or nursing mothers.

How the Study Was Run

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

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

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 2009-05 with completion listed for 2010-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of patients achieving less than [amount hidden] protein per 24 hours after 6 months of Acthar Gel.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 15 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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