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Prospective Study Evaluating the Effect of Repository Corticotropin in the Treatment of Various Nephrotic Syndromes
Plain-language guide to NCT01021540: phase 4 non-randomized trial of ACTH (Corticotropin), 18 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01021540
- Phase
- phase 4
- Status
- completed
- Start
- 2009-12
- Completion (planned or actual)
- 2010-10
- Participants
- 18 (estimated)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Nephrotic Syndromes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested ACTH (Corticotropin).
Acthar Gel (repository corticotrophin) has the same anti-proteinuric effects seen with the synthetic ACTH analogue in Europe.
The registry classes the interventions as drug.
More on the Plan
Synthetic ACTH (Synacthen Depot) has been used in the treatment of Nephrotic Syndrome in Europe.
However, Synacthen is not available in the United States.
The only preparation available is the H.P.
Acthar Gel (repository corticotrophin) which has been widely used in the treatment of infantile spasms and has been available longer than Synacthen.
Who Took Part
The registry lists 18 planned participants were the target.
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 6 inclusion and 16 exclusion criteria; among the exclusions: previous intolerance to native acth or proteins of porcine origin; expected to begin renal replacement therapy or receive a transplant within the next year; history of hiv.
How the Study Was Run
The set-up was non-randomized, 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 2009-12 with completion listed for 2010-10.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Acthar has the same anti-proteinuric effects in a wide range of glomerulonephropaties as seen with synthetic ACTH (Synacthen) in Europe (time frame: 6 months).
It also tracked 1 secondary outcome, for example Acthar has similar anti-lipid effects as seen with Synacthen.
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of ACTH (Corticotropin) in 18 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; 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.