drugset / Trial / NCT05152628
A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the pharmacokinetics of tacrolimus following oral administration of Modigraf, after the first oral dose and at steady state in pediatric participants undergoing de novo allograft liver or kidney transplantation. This study will also observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients.
Timeline
- Start
- 2022-01-11
- Primary completion
- 2024-03-06
- Completion
- 2024-03-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tacrolimus | Small molecule | 0.2 mg/kg | Oral |
Indications
No indication recorded.