Veloxis Pharmaceuticals A/S (OMX: VELO) announced dosing of the first patient in ASERTAA (A Study of Extended Release Tacrolimus in African-Americans) Phase IIIb study of ENVARSUS (formerly LCP Tacro) in kidney transplant recipients. The ASERTAA study is designed to compare the pharmacokinetics (PK) of ENVARSUS, a once-daily tacrolimus tablet, to generic twice daily tacrolimus capsules in stable African-American renal transplant patients.
African-American transplant recipients traditionally experience worse outcomes and require higher doses of immunosuppression. Approximately 50% of African-Americans express the CYP3A5*1 genotype resulting in the need to take high doses of tacrolimus to achieve adequate levels of immunosuppression. This could have implications for dosing with ENVARSUS, which has shown that African-American transplant patients require a reduced dose while maintaining therapeutic levels. This study will measure the reduction in the dose required as well as conduct genotyping on the patients.
“African-American patients may require high doses of tacrolimus to achieve effective treatment,” said Roy D. Bloom M.D., professor of Medicine, medical director, Penn Kidney Pancreas Transplant Program, University of Pennsylvania. “This study will determine if African-American renal transplant patients can benefit from the novel formulation technology of ENVARSUS that may allow for the administration of lower doses to maintain adequate drug exposure, especially in transplant recipients who are expressors of the CYP3A5*1 genotype.”
In this cross-over design, the PK of ENVARSUS in stable African-American renal transplant patients will be compared to the PK of generic twice-daily tacrolimus formulations. In addition, intra-patient variability, total daily dose reduction and analysis of the impact of polymorphic genotype expression will be evaluated. Health-related quality of life, medication adherence and side effect profiles via surveys of study participants will be collected and assessed.
