Adrenal Failure
Conditions
Brief summary
Autoimmune Addison's disease (AAD) is a rare and debilitating disease in which an autoimmune attack progressively destroys the adrenal cortex. Untreated it is universally fatal and treated people are absolutely dependent upon steroid medications lifelong, with a consequent excess in morbidity and mortality. A key feature of the adrenal cortex is that its cells are responsive to changes in circulating adrenocorticotrophic hormone (ACTH) concentration. This study aims to regenerate adrenocortical steroidogenic cell function in patients with established autoimmune Addison's disease (AAD) by stimulating proliferation and differentiation of their progenitor cells, the adrenocortical stem cells (ACSCs) (1,2). Using daily subcutaneous ACTH, administered according to two different regimens over 20 weeks, we will investigate whether regeneration of adrenal steroidogenic function through revival of ACSC activity is a realistic possibility.
Interventions
DRUGdepot tetracosactide
1mg, 3x weekly by sc injection
Sponsors
Newcastle University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 66 Years
Healthy volunteers
No
Inclusion criteria
* Established autoimmune adrenal failure for \>1yr age 16 to 65
Exclusion criteria
* Significant cardio-respiratory, chronic renal or non-autoimmune liver disease; malignancy * Asthma, current infectious disease, recent live vaccination, acute psychosis, peptic ulcer disease * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak serum Cortisol following ACTH stimulation | Tested at 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in QoL | 20 weeks |
Countries
United Kingdom
Outcome results
None listed