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Pilot Study of ACTH in the Treatment of Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
Plain-language guide to NCT02282930: phase 3 interventional trial of ACTH (Corticotropin), 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02282930
- Phase
- phase 3
- Status
- completed
- Start
- 2015-03
- Completion (planned or actual)
- 2018-06-30
- Participants
- 20 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Progressive IgA Nephropathy; Proteinuria
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test ACTH (Corticotropin).
It had 1 arm (groups): ACTH Gel (experimental).
The registry classes the interventions as drug.
Who Took Part
20 actual participants 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: Patient must be able to receive injections to be enrolled in the study. Patients with history of Crohn's disease or Celiac Sprue. Active systemic infection with bacterial, viral, fungal, or mycobacterial or atypical mycobacterial infections (excluding fungal infections of nail beds). Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening. Patients receiving therapy with oral prednisone or glucocorticoid equivalent in the past 3 months.
The full record lists 30 inclusion and 0 exclusion criteria.
How the Study Was Run
The set-up was single-group and open-label.
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 2015-03 with completion listed for 2018-06-30.
It ran at 4 sites in United States (4).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Number of Subjects With a Complete or Partial Response to Treatment (time frame: 12 Months).
It also tracked 1 secondary outcome, for example Number of Subjects to Develop an Infection.
What This Means in Plain Language
Put simply, this is a phase 3 trial of ACTH (Corticotropin) in 20 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.
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.