Pharmacokinetics of Glucocorticoids in Children (GLUCOPED)

NCT02252237 | Completed

• 1 other identifier: 2014-A00987-40
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine individual susceptibility factors (drug interactions, genetic factors such as enzyme polymorphism…) to explain wide interindividual variability towards corticosteroids (prednisone, prednisolone, methylprednisolone, hydrocortisone) in children, which could establish a base for therapeutic monitoring.

Conditions

Children Receiving Prednisone or Prednisolone or Methylprednisolone or Hydrocortisone

Keywords

Prednisone; Prednisolone; Methylprednisolone; Glucocorticoids; pharmacokinetics; hydrocortisone

Outcome Measures

Primary Outcomes (1)

• Composite of Pharmacokinetic parameter for Prednisone, Prednisolone, Methylprednisolone, hydrocortisone

  Assessed by: * Volume of distribution of creatinine * Creatinine clearance

  24 months

Secondary Outcomes (3)

• Side effects

  24 months

• Side effects

  24 months

• Analysis of genetic polymorphism of proteins taking part in glucocorticoids metabolism

  24 months

Study Arms (1)

Children with glucocorticoids

Children receiving Prednisone or Prednisolone or Methylprednisolone Pharmacokinetic

Biological: Pharmacokinetic

Interventions

Pharmacokinetic BIOLOGICAL

Blood sample of 2 ml at enrolment and then at following visits. Buccal cell collection swab

Children with glucocorticoids

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children receiving glucocorticoids (Prednisone or Prednisolone or Methylprednisolone or hydrocortisone) are recruited in Immuno-hematological unit, dermatological unit, in pediatric nephrological unit, pediatric intensive care unit, or pediatric neurology unit

You may qualify if:

• receiving Prednisone or Prednisolone or Methylprednisolone or hydrocortisone
• recruited in Immuno-hematological unit, dermatological unit, in pediatric nephrological unit, pediatric intensive care unit, or pediatric neurology unit
• parental agreement

You may not qualify if:

• parental refusal
• inability to take a blood sample
• inhaled corticoids intake in the 3 previous days
• topical corticoids intake in the 3 previous days

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

AP-HP Necker

Paris, 75015, France

Location

Related Publications (6)

• 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.

  PMID: 15059065 BACKGROUND

• 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.

  PMID: 6721988 BACKGROUND

• 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.

  PMID: 2317067 BACKGROUND

• 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.

  PMID: 12698270 BACKGROUND

• 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.

  PMID: 9832298 BACKGROUND

• 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.

  PMID: 36510685 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Buccal cell collection swab

MeSH Terms

Interventions

Pharmacogenomic Variants

Intervention Hierarchy (Ancestors)

Polymorphism, Genetic; Genetic Variation; Genetic Phenomena

Study Officials

• Jean-Marc Tréluyer, MD-PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: September 30, 2014
• Study Start: December 3, 2014
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)