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Trial · Interventional

CompletedPhase 4Registry data

Revival of Stem Cells in Addison's Study

Short name RoSA

NCTNCT01371526 (opens ClinicalTrials.gov in a new tab)Other idRoSAv1.2:04_10: R&D#5252Other id2009-018074-56Other id2009
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
13 participants (actual)
Sponsor
Newcastle University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United Kingdom

Start
Sept 2010
Primary completion
Sept 2012
Completion
Sept 2012
First posted
13 Jun 2011 (estimated)
Last update posted
6 Feb 2013 (estimated)
Conditions
Adrenal Failure

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013
  1. Ph 4

    RoSA

    NCT01371526

    Sept 2010 to Sept 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • depot tetracosactideDrug

Arms1

  • Experimental

    Synacthen

    active treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Peak serum Cortisol following ACTH stimulation

    Time frame · Tested at 20 weeks

Secondary outcomes(1)

  1. Change in QoL

    Time frame · 20 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2014

Residual adrenal function in autoimmune Addison's disease: improvement after tetracosactide (ACTH1-24) treatment.

Gan et al. 2014The Journal of clinical endocrinology and metabolismcited by 29

PMID 24170102DOI 10.1210/jc.2013-2449PUB-24170102

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 16 Years up to 66 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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