A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients

Phase 2 Completed 19 enrolled Astellas Pharma Inc

Non-randomizedSingle-groupOpen-labelPrevention

Summary

A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Timeline

Start: 2004-01
Primary completion: 2008-10
Completion: 2008-10

Publications

Background Heffron TG, Pescovitz MD, Florman S, Kalayoglu M, Emre S, Smallwood G, Wisemandle K, Anania C, Dhadda S, Sawamoto T, Keirns J, Fitzsimmons W, First MR. Once-daily tacrolimus extended-release formulation: 1-year post-conversion in stable pediatric liver transplant recipients. Am J Transplant. 2007 Jun;7(6):1609-15. doi: 10.1111/j.1600-6143.2007.01803.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Tacrolimus	Small molecule	—	Oral
Background	Tacrolimus	Small molecule	—	Oral

Indications

No indication recorded.