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TerminatedNCT01661387Updated Oct 15, 2024

A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)

An observational study in Chronic Adrenal Insufficiency, sponsored by Shire. Terminated at 24 sites in 5 countries. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Shire (part of Takeda) · Observational

Why this study was terminated
Takeda submitted 900 patient years Interim Analysis to PRAC and requested study to be closed since primary objective had been fulfilled. PRAC agreed and on 17Sep2020 approved closure of EU-AIR Registry. Takeda announced study closure on 31Oct2020.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
3,258
Sex
All
01

Study summary

As a post-approval requirement of the European Medicines Agency, this European patient post authorization safety study is an observational study being conducted to monitor the safety of long-term treatment with Plenadren and other glucocorticoid replacement therapies in routine clinical practice in patients with chronic adrenal insufficiency (primary or secondary).

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Conditions studied

  • Chronic Adrenal Insufficiency

Keywords

  • Adrenal insufficiency
  • DuoCort
  • Congenital adrenal hyperplasia (CAH)
  • Modified release
  • Hydrocortisone
03

In context

Adrenal Insufficiency

135 studies on the registry are indexed under Adrenal Insufficiency; 28 are open to participants now.

This study's enrollment of 3,258 is above the median of 77 across 58 observational studies indexed under Adrenal Insufficiency.

Browse Adrenal Insufficiency studies →

Lead sponsor

Shire is the lead sponsor of 351 studies on the registry; 2 are open to participants now.

Of its 48 completed or terminated interventional studies of FDA-regulated products, 48 (100%) have results posted.

First submitted before Shire became part of Takeda.

Browse Shire studies →All Takeda studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with chronic adrenal insufficiency (primary or secondary) who are receiving Plenadren or other glucocorticoid replacement therapies at endocrinology centres in certain European countries as part of their routine clinical care. Approximately 20 sites are planned for enrollment.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of chronic adrenal insufficiency
  • Written informed consent/assent in compliance with applicable country-specific and local regulations

Exclusion criteria

Exclusion Criteria:

  • Participation in an interventional clinical trial
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
3,258 participants (actual)
Patient registry
No

Groups and cohorts

  • Plenadren

    Modified release hydrocortisone

  • Other Glucocorticoid Replacement Therapy
06

What researchers measure

Primary outcomes

  1. Incidence of intercurrent illness

    Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

    Time frame: approximately 10 years

  2. Incidence of adrenal crisis

    Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

    Time frame: approximately 10 years

  3. Incidence of serious adverse events

    Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

    Time frame: approximately 10 years

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Study locations

24 sites
  • Charité - Universitätsmedizin Berlin
    Berlin, 10117, Germany
  • Endokrinologiepraxis am Stuttgarter Platz
    Berlin, 10627, Germany
  • Friedrich Alexander Universitat Erlangen Nurnberg
    Erlangen, 91054, Germany
  • Universitätsklinikum Frankfurt
    Frankfurt, 60590, Germany
  • LMU Klinikum der Universität München
    München, 80336, Germany
  • Medicover Neuroendokrinologie
    München, 81667, Germany
  • Medicover Oldenburg MVZ
    Oldenburg, 26122, Germany
  • Endokrinologiezentrum Ulm Praxis
    Ulm, 89075, Germany
  • Universitätsklinikum Würzburg
    Würzburg, 97080, Germany
  • Università degli Studi Federico II
    Naples, 80131, Italy
  • Policlinico Umberto I
    Rome, 00161, Italy
  • Policlinico Universitario Agostino Gemelli
    Rome, 00168, Italy
  • Universitair Medisch Centrum Groningen
    Groningen, 9713, Netherlands
  • Erasmus MC
    Rotterdam, 3051, Netherlands
  • Universitair Medisch Centrum Utrecht
    Utrecht, 3584, Netherlands
  • Sahlgrenska Universitetssjukhuset
    Gothenborg, 413 45, Sweden
  • Universitetssjukhuset i Linköping
    Linköping, 58185, Sweden
  • Queen Elizabeth Hospital
    Birmingham, B15 2TH, United Kingdom
  • St James University Hospital
    Leeds, LS9 7TF, United Kingdom
  • Barts and The London NHS Trust
    London, EC1A 7BE, United Kingdom
  • Royal Free Hospital
    London, NW3 2QG, United Kingdom
  • Christie Hospital
    Manchester, M20 4BX, United Kingdom
  • Royal Victoria Infirmary
    Newcastle, NE1 4LP, United Kingdom
  • Churchill Hospital
    Oxford, OX3 9DU, United Kingdom
08

References and documents

Publications

  • Ekman B, Quinkler M, Zhang P, Isidori AM, Murray RD, Wahlberg J; EU-AIR investigators. Mineralocorticoid effects of fludrocortisone and hydrocortisone in primary adrenal insufficiency: EU-AIR patient data. J Endocrinol Invest. 2025 Oct;48(10):2381-2392. doi: 10.1007/s40618-025-02657-7. Epub 2025 Sep 6. PubMed 40913682 ↗
  • Quinkler M, Murray RD, Zhang P, Marelli C, Petermann R, Isidori AM, Ekman B. Characterization of patients with adrenal insufficiency and frequent adrenal crises. Eur J Endocrinol. 2021 May 4;184(6):761-771. doi: 10.1530/EJE-20-1324. PubMed 33769953 ↗
  • Quinkler M, Ekman B, Zhang P, Isidori AM, Murray RD; EU-AIR Investigators. Mortality data from the European Adrenal Insufficiency Registry-Patient characterization and associations. Clin Endocrinol (Oxf). 2018 Jul;89(1):30-35. doi: 10.1111/cen.13609. Epub 2018 Apr 22. PubMed 29682773 ↗
  • Murray RD, Ekman B, Uddin S, Marelli C, Quinkler M, Zelissen PM; the EU-AIR Investigators. Management of glucocorticoid replacement in adrenal insufficiency shows notable heterogeneity - data from the EU-AIR. Clin Endocrinol (Oxf). 2017 Mar;86(3):340-346. doi: 10.1111/cen.13267. Epub 2016 Dec 5. PubMed 27801983 ↗
  • Ekman B, Fitts D, Marelli C, Murray RD, Quinkler M, Zelissen PM. European Adrenal Insufficiency Registry (EU-AIR): a comparative observational study of glucocorticoid replacement therapy. BMC Endocr Disord. 2014 May 9;14:40. doi: 10.1186/1472-6823-14-40. PubMed 24884782 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2012 to primary completion in Oct 2020, 98 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2012
First posted
Aug 9, 2012
StartActual
Aug 7, 2012
Primary completionActual
Oct 31, 2020
CompletionActual
Oct 31, 2020
Last update
Oct 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01661387
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Aug 9, 2012
Start date
Aug 7, 2012
Primary completion
Oct 31, 2020
Completion
Oct 31, 2020
Last update
Oct 15, 2024

Study contacts

Shire Director
study director · Shire

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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