Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar

What Was Tested

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

It had 1 arm (groups): Acthar (experimental).

The study cohort. In this cohort Acthar gel will be administered to the enrolled patient with chrnic AMR.

The registry classes the interventions as drug.

More on the Plan

The patients will be maintained on their center-specific standard maintenance regimen, typically consisting of Tacrolimus, mycephenolate mofetil/Sodium, and prednisone.

After screening for the inclusion/exclusion criteria, the patients will be consented and enrolled in the study.

Donor-specific antibody (DSA) will be tested at week 24, and 52 and patients will undergo a biopsy at week 52, as a part of the investigators standard of care.

The biopsies will be evaluated by light and electron microscopy using standard histological Banff criteria, and staining for CD68.

Who Took Part

The registry lists 6 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 years. Morphologic diagnosis of CAMR, by light \&/or electron microscopy any time after transplantation. Current or previously documented donor-specific antibody (DSA) and/or focal or diffuse peritubular capillary C4d staining by immunohistochemistry.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: lack of evidence of antibody involvement; pregnancy, lactation, or refusal to use birth control in women of child bearing potential; active infection, or history of hiv.

How the Study Was Run

The set-up was single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-08 with completion listed for 2021-05-27.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Safety (Serious Adverse Events) (time frame: 12 months).

What This Means in Plain Language

Put simply, this is a phase 4 trial of ACTH (Corticotropin) in 6 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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