drugset / Trial / NCT01614665
A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time
RandomizedParallel-groupOpen-labelOther
Summary
The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and effective they are over a longer period of time. This study is for children less than 16 years old. No minimum age has been set, however, to be included in this study participants must able to swallow the medication capsules intact.
Timeline
- Start
- 2012-04-03
- Primary completion
- 2021-04-21
- Completion
- 2021-04-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tacrolimus | Small molecule | 0.075 mg/kg | Oral |
| Comparator | Tacrolimus | Small molecule | 0.3 mg/kg | Oral |
Indications
No indication recorded.