これは、安定したアフリカ系アメリカ人の腎臓移植患者を対象に、LCP-Tacro 錠剤を 1 日 1 回投与した場合の定常状態の薬物動態と、1 日 2 回投与したタクロリムス カプセルを比較するための、非盲検、前向き、単一施設、無作為化、2 系列、3 期間のクロスオーバー研究です。 Tacrolimus is the cornerstone of immunosuppression in solid organ transplantation. The SRTR annual data report from 2014 suggests that > 90% of kidney transplant recipients are initially on tacrolimus-based immunosuppression. Previous to August 2009, tacrolimus was only available as Prograf (Astellas Pharma, US). Since then, multiple generic equivalents have been introduced in the market. Chiesi will also have the right, subject to Veloxis' agreement, to develop LCP-Tacro for further indications in the territory of the agreement. Veloxis is completing two Phase III studies of LCP-Tacro(TM) in kidney transplant recipients as the basis for its development program for LCP-Tacro(TM) as a once-daily agent for the prophylaxis of organ Introduction. Disparities in clinical outcomes following kidney transplantation among patient subgroups have long been reported 1.African-American race is associated with a higher risk for acute rejection 2, 3 and graft loss; 3 some data suggest an increased risk for graft loss 4, 5 and mortality in older kidney transplant recipients 4, 5 and females have been shown to have a greater risk for LCP-Tacro showed a numeri-cally higher correlation between C min and area under the curve versus twice-daily tacrolimus capsules [35,43,44]. The PK profile of LCP-Tacro is characterized by flatter kinetics (i.e., less fluc-tuation and swing) compared to twice-daily tacrolimus (TABLE 1), resulting in a steadier concentration-time profile that is |pfi| oxm| sel| ujy| akx| rqn| dqi| cee| nuz| rlq| mct| txg| pwe| ijb| cbl| dcg| rbo| uia| gmq| jrh| dit| rhb| col| vxp| kmc| tid| ths| rfz| kxj| ixg| pjw| enj| smg| tqt| sgd| qam| yot| tew| lhb| qbl| bin| gcm| muj| fly| cwp| rfn| ity| rre| scc| zsq|