Children Receiving Prednisone or Prednisolone or Methylprednisolone or HydrocortisoneGLUCOPEDNCT02252237
Pharmacokinetics of Glucocorticoids in Children (GLUCOPED)
An observational study of Children Receiving Prednisone or Prednisolone or Methylprednisolone or Hydrocortisone, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Children Receiving Prednisone or Prednisolone or Methylprednisolone or Hydrocortisone
- What is being tested?
- Pharmacokinetic
- How many people
- 146 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2014to 9 Dec 2021
- 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: 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
Who may be able to join
- 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
Who cannot join
- parental refusal
- inability to take a blood sample
- inhaled corticoids intake in the 3 previous days
- topical corticoids intake in the 3 previous days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Pharmacokinetic Variability of Glucocorticoids in Children
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.
Read the detailed description
Corticosteroids are widely used in children. A large interindividual variability exists concerning both efficacity and tolerance. Pharmacokinetic is poorly known.
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.
- Being tested
- Pharmacokinetic
- Keywords
- Prednisone, Prednisolone, Methylprednisolone, Glucocorticoids, pharmacokinetics, hydrocortisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmacokineticBiological
Blood sample of 2 ml at enrolment and then at following visits. Buccal cell collection swab
| Study group | Role | What they receive |
|---|---|---|
| Children with glucocorticoids | Children receiving Prednisone or Prednisolone or Methylprednisolone Pharmacokinetic Receives: Biological: Pharmacokinetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Pharmacokinetic parameter for Prednisone, Prednisolone, Methylprednisolone, hydrocortisone
Assessed by:
- Volume of distribution of creatinine
- Creatinine clearance
Measured: 24 months
Secondary outcomes (3)
Side effects
Ferryman and Gallwey score
Measured: 24 months
Side effects
Dermaphot® score
Measured: 24 months
Analysis of genetic polymorphism of proteins taking part in glucocorticoids metabolism
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study start3 Dec 2014
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Children Receiving Prednisone or Prednisolone or Methylprednisolone or HydrocortisoneStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jean-Marc Tréluyer, MD-PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252237
- Sponsor's protocol ID
- 2014-A00987-40
- Acronym
- GLUCOPED
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2014
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 15059065Gatti 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.
PubMed 6721988Miller 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.
PubMed 2317067Petersen 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.
PubMed 12698270Faure 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.
PubMed 9832298de 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.
PubMed 36510685
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pharmacokinetic Variability of Glucocorticoids in Children
- ClinicalTrials.gov ID
- NCT02252237
- Acronym / sponsor ID
- GLUCOPED / 2014-A00987-40
- Keywords
- Prednisone, Prednisolone, Methylprednisolone, Glucocorticoids, pharmacokinetics, hydrocortisone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 3 Dec 2014 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 30 Sep 2014 (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.
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.
Detailed description
Corticosteroids are widely used in children. A large interindividual variability exists concerning both efficacity and tolerance. Pharmacokinetic is poorly known.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with glucocorticoids | – | Biological: PharmacokineticChildren receiving Prednisone or Prednisolone or Methylprednisolone Pharmacokinetic |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- parental refusal
- inability to take a blood sample
- inhaled corticoids intake in the 3 previous days
- topical corticoids intake in the 3 previous days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PharmacokineticBlood sample of 2 ml at enrolment and then at following visits. Buccal cell collection swab | Biological | Children with glucocorticoids |
Primary outcome
Composite of Pharmacokinetic parameter for Prednisone, Prednisolone, Methylprednisolone, hydrocortisone
Time frame: 24 months
Assessed by: * Volume of distribution of creatinine * Creatinine clearance
3 secondary outcomes
Side effects
Time frame: 24 months
Side effects
Time frame: 24 months
Analysis of genetic polymorphism of proteins taking part in glucocorticoids metabolism
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 15059065Jamroziak 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.
- Background: PubMed 6721988Gatti 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.
- Background: PubMed 2317067Miller 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.
- Background: PubMed 12698270Petersen 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.
- Background: PubMed 9832298Faure 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.
- Results publication: PubMed 36510685de 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.
- Individual participant dataSharing planned: No
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.
Jean-Marc Tréluyer, MD-PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children Receiving Prednisone or Prednisolone or Methylprednisolone or Hydrocortisone, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite of Pharmacokinetic parameter for Prednisone, Prednisolone, Methylprednisolone, hydrocortisone (time frame: 24 months). 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 NCT02252237, which also lists 6 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 20 Nov 2025.