Status:
COMPLETED
Rescue of Steroidogenic Capacity in Adrenocortical Failure Study (RADS)
Lead Sponsor:
Newcastle University
Collaborating Sponsors:
Newcastle-upon-Tyne Hospitals NHS Trust
Conditions:
Autoimmune Adrenocortical Failure
Eligibility:
All Genders
16-65 years
Phase:
PHASE4
Brief Summary
This is a pilot study of B lymphocyte depletion therapy in an attempt to salvage adrenal steroidogenic capacity in ten subjects with early autoimmune Addison's disease. During the first twelve weeks o...
Eligibility Criteria
Inclusion
- Clear evidence of primary adrenal failure (elevated ACTH, pigmentation, electrolyte disturbance)
- Basal or stimulated cortisol \<400 nmol/l but \>100nmol/l
Exclusion
- Active viral infection, pregnancy or breast feeding, previous immunosuppression, diabetes, cardiorespiratory disease, renal failure, hepatic disease, cancer
- Calcified or enlarged adrenals on CT scan, active TB
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00753597
Start Date
September 1 2008
End Date
April 1 2012
Last Update
February 6 2013
Active Locations (1)
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1
Clinical Research Facility, Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP