Some of the data were presented at the 2008 American Transplant Congress in Toronto, Canada, and at the 2012 American Transplant Congress in Boston, MA.
Conversion from twice daily tacrolimus capsules to once daily extended-release tacrolimus (LCP-Tacro): Phase 2 trial of stable liver transplant recipients
Article first published online: 26 MAR 2014
© 2014 American Association for the Study of Liver Diseases
Volume 20, Issue 5, pages 564–575, May 2014
How to Cite
Alloway, R. R., Eckhoff, D. E., Washburn, W. K. and Teperman, L. W. (2014), Conversion from twice daily tacrolimus capsules to once daily extended-release tacrolimus (LCP-Tacro): Phase 2 trial of stable liver transplant recipients. Liver Transpl, 20: 564–575. doi: 10.1002/lt.23844
The ClinicalTrials.gov identifier for this study is NCT00608244.
Funding for this study was provided by Veloxis Pharmaceuticals.
Rita R. Alloway received grant funding from Veloxis Pharmaceuticals; Devin E. Eckhoff, W. Kenneth Washburn, and Lewis W. Teperman have nothing to disclose.
- Issue published online: 25 APR 2014
- Article first published online: 26 MAR 2014
- Accepted manuscript online: 3 FEB 2014 09:31AM EST
- Manuscript Accepted: 21 JAN 2014
- Manuscript Received: 12 NOV 2013
- 5Astellas Pharma US. Highlights of prescribing information. http://www.astellas.us/docs/prograf.pdf. Accessed January 2014.
- 12Efficacy, safety, and immunosuppressant adherence in stable liver transplant patients converted from a twice-daily tacrolimus-based regimen to once-daily tacrolimus extended-release formulation. Transpl Int 2011;24:666-675., , , , , , et al.
- 13Food and Drug Administration. Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products—general considerations. http://www.fda.gov/downloads/Drugs/./Guidances/ucm070124.pdf. Published March 2003. Accessed January 2014.
- 15European Agency for the Evaluation of Medicinal Products. Note for guidance on modified release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003126.pdf. Accessed January 2014.
- 18Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2011 Annual Data Report. Rockville, MD: Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation; 2012.
- 19Long-term management of the successful adult liver transplant: 2012 practice guideline by the American Association for the Study of Liver Diseases and the American Society of Transplantation. Liver Transpl 2013;19:3-26., , , , , , .