Trials / Completed
CompletedNCT01371331
A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation
A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus Granules) in de Novo Paediatric Allograft Recipients
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Astellas Pharma Europe Ltd. · Industry
- Sex
- All
- Age
- 0 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics). The results will then help to decide how much Modigraf in future can be given safely to children and young people following transplantation.
Detailed description
The primary objective of this study is to determine the pharmacokinetics (PK) of tacrolimus following oral administration of Modigraf, after the first oral dose and at steady state in paediatric subjects undergoing de novo allograft transplantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tacrolimus granules | oral |
Timeline
- Start date
- 2011-06-09
- Primary completion
- 2015-02-03
- Completion
- 2015-02-03
- First posted
- 2011-06-10
- Last updated
- 2024-11-01
Locations
10 sites across 6 countries: Belgium, France, Germany, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01371331. Inclusion in this directory is not an endorsement.