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Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy
Plain-language guide to NCT00694863: phase 2 interventional trial of Cosyntropin, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00694863
- Phase
- phase 2
- Status
- completed
- Start
- 2008-07
- Completion (planned or actual)
- 2010-12
- Participants
- 20 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Idiopathic Membranous Nephropathy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Cosyntropin.
The purpose of this study is to determine whether treatment with long-acting synthetic adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous nephropathy and high for renal failure.
It had 1 arm (groups): 1 (experimental).
In this open-label study all patients included are treated in the experimental group.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 20 actual participants took part.
It was open to people of any sex aged from 18 years up to 95 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Biopsy-proven idiopathic membranous nephropathy. High risk for renal failure: beta-2-microglobulin excretion \> 500 ng/min. Relative contra-indication for cyclophosphamide treatment:. Fertility and wish for (future) family expanding. High age ( \> 60 years).
The full record lists 9 inclusion and 7 exclusion criteria; among the exclusions: clinical,biochemical or histological signs of any underlying systemic disease; any infectious disease (including latent tuberculosis and/or latent amoebiasis); active gastric or duodenal ulcers.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the Cosyntropin study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2008-07 with completion listed for 2010-12.
It ran at 1 site in Netherlands.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Attainability of ACTH therapy with intramuscular injections twice a week for a period of 9 months, measured as the percentage of injections that has been received in line with the treatment schedule (time frame: 9 months).
What This Means in Plain Language
Put simply, this is a phase 2 trial of Cosyntropin in 20 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 Cosyntropin compound page, all human trials.
Our Notes on the Compound
Cosyntropin: A synthetic 24-amino-acid fragment of ACTH (also tetracosactide, Synacthen) used mainly in the adrenal stimulation test.
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.