Prospective, Rand, Open-label, Single-center, 2 Sequence, 3 Period Crossover Study to Compare the Steady State PK of Once-Daily-Extended Release LCP-Tacro to Generic Tacrolimus Capsules Twice Daily in Stable A A Renal Transplant pt.
Phase of Trial: Phase III
Latest Information Update: 16 Aug 2016
At a glance
- Drugs Tacrolimus (Primary)
- Indications Renal transplant rejection
- Focus Pharmacokinetics; Registrational
- Acronyms ASERTAA
- Sponsors Veloxis Pharmaceuticals
- 07 Jun 2017 Biomarkers information updated
- 29 Jun 2016 According to a Veloxis Pharmaceuticals media release, based on the findings from this study the company has received approval for label enhancement for the Envarsus (Tacrolimus extended-release) package insert. The FDA-approved label now contains ethnicity-specific dosing and unique genotyping guidance to Envarsus XR.
- 29 Jun 2016 Results published in a Veloxis Pharmaceuticals media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History