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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.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plenadren | Modified release hydrocortisone | ||
| Other Glucocorticoid Replacement Therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intercurrent illness | Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI | 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 | 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 | approximately 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Shire Director | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany | |||
| Endokrinologiepraxis am Stuttgarter Platz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40913682 | Derived | 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. | |
| 33769953 | Derived |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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| 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 |
| 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. |
| 29682773 | Derived | 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. |
| 27801983 | Derived | 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. |
| 24884782 | Derived | 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. |
| ID | Term |
|---|---|
| D000309 | Adrenal Insufficiency |
| D000312 | Adrenal Hyperplasia, Congenital |
| ID | Term |
|---|---|
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D047808 | Adrenogenital Syndrome |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D043202 | Steroid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006058 | Gonadal Disorders |
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