A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy

What Was Tested

The trial (phase 3) is built around ACTH (Corticotropin).

It had four arms (groups): Phase 3a Cohort 1 (experimental), Phase 3a Cohort 2 (experimental), Phase 3b Cohort 1 (experimental) and Phase 3b Cohort 2 (active comparator).

The registry classes the interventions as drug.

More on the Plan

The trial will be divided into 2 parts: Phase 3a and Phase 3b.

Who Took Part

148 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: Biopsy-proven membranous glomerulonephritis or a diagnosis of MN in patients with Nephrotic Syndrome and a positive anti PLA2R antibody test. Life expectancy \> 24 months. Other inclusion criteria may apply.

The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: secondary membranous nephropathy as defined by history, physical exam, kidney biopsy results or serologies; type 1 or 2 diabetes mellitus; patients who must be initiated on drugs likely to affect renal function if not properly dosed.

How the Study Was Run

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

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.

Being open-label, the ACTH (Corticotropin) study did not mask who received what.

It started in 2023-03-13 with completion listed for 2027-04-01.

It ran at 31 sites in United States (19), India (11) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in urinary protein (Phase 3a) (time frame: Change from baseline, months 1, 2, 3, 4, 5, 6, 9, and 12). Change in Anti-phospholipase A2 receptor (PLA2R) auto-antibody levels (Phase 3a) (time frame: Change from baseline, months 1, 2, 3, 4, 6, and 12). Complete response of PMN (Phase 3b) (time frame: 24 months).

It also tracked 10 secondary outcomes, for example Relapse rate at month 12 and month 24, Anti-PLA2R (or Anti-THSD7A) auto-antibody levels, Estimated glomerular filtration rate (eGFR) with proteinuria levels, Adverse events, Incidence of ADAs and Number of patients who achieved a complete remission (CR) or partial remission (PR) at month 12.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of ACTH (Corticotropin) in 148 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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