A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation

Phase 4 Completed 52 enrolled Astellas Pharma Europe Ltd.

NaSingle-groupOpen-labelPrevention

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.

Timeline

Start: 2011-06-09
Primary completion: 2015-02-03
Completion: 2015-02-03

Publications

Webb NJA, Baumann U, Camino M, Frauca E, Undre N; OPTION Study Group. Pharmacokinetics of tacrolimus granules in pediatric de novo liver, kidney, and heart transplantation: The OPTION study. Pediatr Transplant. 2019 Feb;23(1):e13328. doi: 10.1111/petr.13328. Epub 2019 Jan 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tacrolimus	Small molecule	0.15 mg/kg	Oral

Indications

No indication recorded.