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ACTHAR GEL in Patients With Membranous (Class V) Lupus Nephritis
Plain-language guide to NCT01926054: phase 4 randomized trial of ACTH (Corticotropin), lupus (sle). Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01926054
- Phase
- phase 4
- Status
- withdrawn
- Start
- 2013-07
- Completion (planned or actual)
- 2018-02
- Participants
- n/a (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- SLE Glomerulonephritis Syndrome, WHO Class V
- 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) for lupus (sle).
It had two arms (groups): one (active comparator) and one (active comparator).
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.
The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: patients \< 18 years of age; kidney biopsy with active class iii or iv ln; patients with hepatitis b, c, hiv, tb or other active and chronic infections at the time of screening.
How the Study Was Run
Design: randomized, parallel-group and open-label.
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.
The ACTH (Corticotropin) group and the comparison group ran side by side rather than switching.
Being open-label, the ACTH (Corticotropin) study did not mask who received what.
It started in 2013-07 with completion listed for 2018-02.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Number of participants with adverse events (time frame: Baseline and Month 12). Change in laboratory data (time frame: Baseline and Month 12). Renal Response to Acthar Gel (time frame: Baseline and Month 6).
It also tracked 3 secondary outcomes, for example Change in remission, Change baseline SLE laboratory and Change in extra-renal systemic lupus erythematosus disease activity index.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in people with lupus (sle).
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.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, Lupus (SLE) research.
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.