Pharmacokinetics of Glucocorticoids in Children (GLUCOPED)
NCT ID: NCT02252237
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
146 participants
OBSERVATIONAL
2014-12-03
2021-12-09
Brief Summary
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Detailed Description
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A knowledge of individual susceptibility factors would allow to better adapt therapy in each case.
Drugs evaluated here are used in routine care in children and will be prescribed according to department practices concerning treated disease. Medical checks will be done during usual follow-up. Several features will be collected: reason of treatment, drug chosen and prescription modalities, observance, concomitant treatments, side effects, clinical examination, photography, score… Blood samples will be performed at different interval during usual biological follow-up. Three samples per patient will be required for pharmacokinetic and pharmacogenetic.
170 children under prednisone/prednisolone,130 under methylprednisolone, and 100 children under hydrocortisone will be recruited in four pediatric medical departments: immuno-hematology, nephrology,dermatology, and pediatric neurology.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Children with glucocorticoids
Children receiving Prednisone or Prednisolone or Methylprednisolone Pharmacokinetic
Pharmacokinetic
Blood sample of 2 ml at enrolment and then at following visits. Buccal cell collection swab
Interventions
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Pharmacokinetic
Blood sample of 2 ml at enrolment and then at following visits. Buccal cell collection swab
Eligibility Criteria
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Inclusion Criteria
* recruited in Immuno-hematological unit, dermatological unit, in pediatric nephrological unit, pediatric intensive care unit, or pediatric neurology unit
* parental agreement
Exclusion Criteria
* inability to take a blood sample
* inhaled corticoids intake in the 3 previous days
* topical corticoids intake in the 3 previous days
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jean-Marc Tréluyer, MD-PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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AP-HP Necker
Paris, , France
Countries
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References
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Petersen KB, Jusko WJ, Rasmussen M, Schmiegelow K. Population pharmacokinetics of prednisolone in children with acute lymphoblastic leukemia. Cancer Chemother Pharmacol. 2003 Jun;51(6):465-73. doi: 10.1007/s00280-003-0602-3. Epub 2003 Apr 16.
Jamroziak K, Mlynarski W, Balcerczak E, Mistygacz M, Trelinska J, Mirowski M, Bodalski J, Robak T. Functional C3435T polymorphism of MDR1 gene: an impact on genetic susceptibility and clinical outcome of childhood acute lymphoblastic leukemia. Eur J Haematol. 2004 May;72(5):314-21. doi: 10.1111/j.1600-0609.2004.00228.x.
Gatti G, Perucca E, Frigo GM, Notarangelo LD, Barberis L, Martini A. Pharmacokinetics of prednisone and its metabolite prednisolone in children with nephrotic syndrome during the active phase and in remission. Br J Clin Pharmacol. 1984 Apr;17(4):423-31. doi: 10.1111/j.1365-2125.1984.tb02367.x.
Miller PF, Bowmer CJ, Wheeldon J, Brocklebank JT. Pharmacokinetics of prednisolone in children with nephrosis. Arch Dis Child. 1990 Feb;65(2):196-200. doi: 10.1136/adc.65.2.196.
Faure C, Andre J, Pelatan C, Munck A, Giraud M, Cezard JP, Jacqz-Aigrain E. Pharmacokinetics of intravenous methylprednisolone and oral prednisone in paediatric patients with inflammatory bowel disease during the acute phase and in remission. Eur J Clin Pharmacol. 1998 Sep;54(7):555-60. doi: 10.1007/s002280050512.
de Truchis C, Bouazza N, Foissac F, Charbit M, Dehoux L, Lui G, Ribot M, Briand N, Zheng Y, Treluyer JM, Boyer O. Prednisolone pharmacokinetics after oral prednisone administration in paediatric patients with kidney transplant. Br J Clin Pharmacol. 2023 May;89(5):1532-1540. doi: 10.1111/bcp.15610. Epub 2022 Dec 12.
Other Identifiers
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2014-A00987-40
Identifier Type: -
Identifier Source: org_study_id
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