A Dose Escalation Study of Long-acting ACTH Gel in Membranous Nephropathy

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test ACTH (Corticotropin).

Membranous Nephropathy (MN) is an immune-mediated kidney disease that affects the glomerulus or the filter that removes toxins from the blood.

Damage to the membrane that separates blood from urine results in loss of protein into the urine (proteinuria) and in some cases loss of kidney function.There is no standard specific treatment for MN.

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

The registry classes the interventions as drug.

Who Took Part

10 actual participants took part.

It was open to people of any sex aged from 18 years up to 72 years.

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

Examples of who could join: Proteinuria as measured by Uprot/Ucr \> 4.0 on a spot sample aliquot from a 24-hour urine collection. The choice of Uprot/UCr is in accord with recent NKF-CKD guidelines.\[9\].

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: patient must be off glucocorticoid, calcineurin inhibitors (cyclosporin a, tacrolimus) or mycophenolic mofetil for \> 1 month, and alkylating agents or rituximab for \>6 months; resistance to the following immunosuppressive routines e.g. steroids alone, calcineurin inhibitors plus or minus steroids, cytotoxic agents plus or minus steroids; pregnancy or nursing - for safety reasons.

How the Study Was Run

It was run as a randomized, parallel-group and open-label 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.

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

It started in 2010-02 with completion listed for 2013-01.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: change in proteinuria from baseline to value at 3 months (time frame: 3 months).

It also tracked 2 secondary outcomes, for example Complete Remission(CR) or Partial Remission (PR) at 3 months and Adverse effects.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of ACTH (Corticotropin) in 10 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.