← Human Trials & Peer-Reviewed Studies
Acthar for Treatment of Post-transplant FSGS
Plain-language guide to NCT02399462: phase 4 interventional trial of ACTH (Corticotropin). Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02399462
- Phase
- phase 4
- Status
- withdrawn
- Start
- 2021-03
- Completion (planned or actual)
- 2021-07-31
- Participants
- n/a (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- FSGS; Renal Transplantation; Kidney Transplantation
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test ACTH (Corticotropin).
This is an open label safety and feasibility trial using Acthar® in addition to center-specific standard therapy including plasma exchange, for treatment of post transplant recurrent FSGS and post transplant recurrent idiopathic membranous nephropathy.
It had 1 arm (groups): Study Drug Arm (experimental).
Acthar SC injections.
The registry classes the interventions as drug.
Who Took Part
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: Age \> 18 years. FSGS confirmed by renal transplant biopsy (FSGS on light microscopy and/or foot process effacement on electron microscopy), within 18 months post transplant.
The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: lactation, pregnancy or refusal of birth control in women of childbearing potential; infection with human immunodeficiency virus (hiv), hepatitis b, hepatitis c, or parvovirus b-19; non-renal organ transplant (with the exception of pancreas transplant).
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 2021-03 with completion listed for 2021-07-31.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): number of patients with proteinuria (time frame: 24 and 52 weeks).
It also tracked 2 secondary outcomes, for example Graft loss and eGFR change.
What This Means in Plain Language
Put simply, this is a phase 4 trial of ACTH (Corticotropin) in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the ACTH (Corticotropin) compound page, all human trials.
Our Notes on the Compound
ACTH (Corticotropin): The 39-amino-acid pituitary hormone that drives cortisol production; given as repository corticotropin (Acthar Gel).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.