Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation

What Was Tested

This registered phase 3 trial tested ACTH (Corticotropin).

This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence.

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

The registry classes the interventions as drug.

More on the Plan

This is a prospective study enrolling renal transplant recipients with the primary native kidney disease of FSGS.

Primary endpoint is rate of recurrence of FSGS as seen in renal transplant biopsies and in rate of proteinuria.

Secondary endpoint is renal function after transplantation The target subject number is 20 patients and the target population is primary FSGS patients.

Therefore, it would be expected that at least 4 patients will develop recurrent FSGS after renal transplantation.

Who Took Part

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: To receive either a live donor or deceased donor kidney transplant.

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: not having fsgs.

How the Study Was Run

It was run as a single-group and open-label study.

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

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

It started in 2019-02-01 with completion listed for 2024-06-06.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Rate of Recurrence of FSGS as Seen in Renal Transplant Biopsies Proteinuria (time frame: 2 years). Rate of Recurrence of Proteinuria (time frame: 2 years).

It also tracked 1 secondary outcome, for example Renal Function After Transplantation.

What This Means in Plain Language

Put simply, this is a phase 3 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; results are posted on the registry, and this page does not restate them.

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