Autoimmune Addison's disease MedDRA version: 9.1 Level: HLT Classification code 10001343 Term: Adrenal cortical hypofunction
Conditions
Interventions
Trade Name: Synacthen Depot
Product Name: Synacthen Depot
Pharmaceutical Form: Suspension for injection
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects between 16 and 65 years of age - Adrenocortical failure, as judged by a basal cortisol of less than 100nmol/l or peak ACTH-stimulated cortisol response of less than 300nmol/l that was established a minimum of 1 year previously and persists at run-in assessments - Elevation of ACTH at diagnosis or during testing in the run-in phase of the study - Positive adrenal antibodies at baseline or recorded during illness - Normal or atrophic adrenal glands on CT scan - Willingness to travel to Newcastle CRF for study - Willingness to attend education sessions about indications for parenteral glucocorticoid administration and technique of administration - Female participants of child-bearing age will be willing to take acceptable contraception during study, and for 3 months following last synacthen dose Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Significant cardio-respiratory, chronic renal or non-autoimmune liver disease; malignancy - Pregnancy, breast feeding or plan for pregnancy within 9 months - Known non-autoimmune cause for adrenal failure (haemorrhage, adrenoleukodystrophy etc.) - Known hypersensitivity or allergy to Synacthen, synacthen depot or zinc salts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We wish to find out whether repeated stimulation of adrenocortical stem cells with synacthen (synthetic ACTH peptide) can regenerate adrenal function in established autoimmune Addison's disease (adrenal failure). This might be possible because stem cells are probably not destroyed by the autoimmune attack in Addison's disease, they likely remain dormant because ACTH levels drop following treatment with replacement steroids.;Secondary Objective: Is this a safe regimen of treatment;Primary end point(s): • Restoration of adrenocortical synthetic function, as judged by either: basal cortisol >400nmol/l (rise in 300nmol/l over pre-treatment), or synacthen-stimulated cortisol >550nmol/l (rise in 250nmol/l over pre-treatment) at 30 or 60 min after iv synacthen 250µg. | — |
Countries
United Kingdom
Outcome results
None listed