Revival of Stem Cells in Addison's Study (RoSA)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

SHS Pearce, Newcastle University

ClinicalTrials.gov Identifier:

NCT01371526

First received: March 9, 2011

Last updated: February 5, 2013

Last verified: February 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Adrenal Failure	Drug: depot tetracosactide	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Revival of Autochthonous Adrenocortical Stem Cells in Autoimmune Addison's Disease

Resource links provided by NLM:

MedlinePlus related topics: Addison Disease

Drug Information available for: Cosyntropin

U.S. FDA Resources

Further study details as provided by Newcastle University:

Primary Outcome Measures:

Peak serum Cortisol following ACTH stimulation [ Time Frame: Tested at 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in QoL [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	September 2010
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Synacthen active treatment	Drug: depot tetracosactide 1mg, 3x weekly by sc injection

Eligibility

Ages Eligible for Study:	16 Years to 66 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371526

Locations

United Kingdom
Newcastle University
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 3BZ

Sponsors and Collaborators

Newcastle University

Investigators

Principal Investigator:

Simon H Pearce, MD

Newcastle University

More Information

No publications provided

Responsible Party:	SHS Pearce, Professor of Endocrinology, Newcastle University
ClinicalTrials.gov Identifier:	NCT01371526 History of Changes
Other Study ID Numbers:	RoSAv1.2:04_10: R&D#5252, 2009-018074-56
Study First Received:	March 9, 2011
Last Updated:	February 5, 2013
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Cosyntropin

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013

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