Chronic Adrenal InsufficiencyNCT01661387
A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)
An observational study of Chronic Adrenal Insufficiency, run by Shire at 24 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Adrenal Insufficiency
- How many people
- 3,258 participants
- Where
- 24 sitesin 5 countries
- Study dates
- 7 Aug 2012to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Diagnosis of chronic adrenal insufficiency
- Written informed consent/assent in compliance with applicable country-specific and local regulations
Who cannot join
- Participation in an interventional clinical trial
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
Germany9 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Endokrinologiepraxis am Stuttgarter Platz
Berlin, 10627
Friedrich Alexander Universitat Erlangen Nurnberg
Erlangen, 91054
Universitätsklinikum Frankfurt
Frankfurt, 60590
LMU Klinikum der Universität München
München, 80336
Medicover Neuroendokrinologie
München, 81667
Medicover Oldenburg MVZ
Oldenburg, 26122
Endokrinologiezentrum Ulm Praxis
Ulm, 89075
Universitätsklinikum Würzburg
Würzburg, 97080
United Kingdom7 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
St James University Hospital
Leeds, LS9 7TF
Barts and The London NHS Trust
London, EC1A 7BE
Royal Free Hospital
London, NW3 2QG
Christie Hospital
Manchester, M20 4BX
Royal Victoria Infirmary
Newcastle, NE1 4LP
Churchill Hospital
Oxford, OX3 9DU
Italy3 sites
Università degli Studi Federico II
Naples, 80131
Policlinico Umberto I
Rome, 00161
Policlinico Universitario Agostino Gemelli
Rome, 00168
Netherlands3 sites
Universitair Medisch Centrum Groningen
Groningen, 9713
Erasmus MC
Rotterdam, 3051
Universitair Medisch Centrum Utrecht
Utrecht, 3584
Sweden2 sites
Sahlgrenska Universitetssjukhuset
Gothenborg, 413 45
Universitetssjukhuset i Linköping
Linköping, 58185
About this study
Official title: A European, Multi-Centre, Multi-Country, Post-Authorisation, Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)
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).
- Conditions
- Chronic Adrenal Insufficiency
- Keywords
- Adrenal insufficiency, DuoCort, Congenital adrenal hyperplasia (CAH), Modified release, Hydrocortisone
- Medical subject headings
- Adrenal Insufficiency, Adrenal Hyperplasia, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Plenadren | Modified release hydrocortisone | |
| Other Glucocorticoid Replacement Therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intercurrent illness
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Measured: approximately 10 years
Incidence of adrenal crisis
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Measured: approximately 10 years
Incidence of serious adverse events
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Measured: approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study start7 Aug 2012
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Adrenal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shire Director, Study director, Shire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661387
- Sponsor's protocol ID
- 0918-400
- Status last verified
- Oct 2024
- First submitted
- 6 Aug 2012
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
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 40913682Quinkler 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 33769953Quinkler 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 29682773Murray 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 27801983Ekman 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A European, Multi-Centre, Multi-Country, Post-Authorisation, Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)
- ClinicalTrials.gov ID
- NCT01661387
- Acronym / sponsor ID
- 0918-400
- Conditions
- Chronic Adrenal Insufficiency
- Keywords
- Adrenal insufficiency, DuoCort, Congenital adrenal hyperplasia (CAH), Modified release, Hydrocortisone
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 3,258 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2012 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plenadren | – | –Modified release hydrocortisone |
| Other Glucocorticoid Replacement Therapy | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of chronic adrenal insufficiency
- Written informed consent/assent in compliance with applicable country-specific and local regulations
Key exclusion criteria (1 listed)
- Participation in an interventional clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of intercurrent illness
Time frame: approximately 10 years
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Incidence of adrenal crisis
Time frame: approximately 10 years
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Incidence of serious adverse events
Time frame: approximately 10 years
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 40913682Ekman 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.
- Derived from this study: PubMed 33769953Quinkler 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.
- Derived from this study: PubMed 29682773Quinkler 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.
- Derived from this study: PubMed 27801983Murray 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.
- Derived from this study: PubMed 24884782Ekman 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.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shire Director study director
Shire
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Adrenal Insufficiency, run by Shire at 24 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, United Kingdom, Italy, Netherlands, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intercurrent illness (time frame: approximately 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01661387, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.