Revival of autochthonous adrenocortical stem cells in autoimmune Addison’s disease (RoSA) - Revival of Stem cells in Addison's disease (RoSA)

• Register: EUCTR
• Last refreshed on: 3 December 2012
• Main ID: EUCTR2009-018074-56-GB
• Date of registration: 18/03/2010
• Prospective Registration: Yes
• Primary sponsor: Newcastle upon Tyne Hospitals NHS Foundation Trust
• Public title: Revival of autochthonous adrenocortical stem cells in autoimmune Addison’s disease (RoSA) - Revival of Stem cells in Addison's disease (RoSA)
• Scientific title: Revival of autochthonous adrenocortical stem cells in autoimmune Addison’s disease (RoSA) - Revival of Stem cells in Addison's disease (RoSA)
• Date of first enrolment: 05/05/2010
• Target sample size: 12
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-018074-56
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

United Kingdom

Key inclusion & exclusion 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:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Autoimmune Addison's disease
MedDRA version: 9.1 Level: HLT Classification code 10001343 Term: Adrenal cortical hypofunction

Intervention(s)

Trade Name: Synacthen Depot
Product Name: Synacthen Depot
Pharmaceutical Form: Suspension for injection

Primary Outcome(s)

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.

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

Secondary ID(s)

G0900001:RoSAv1.1:12_09