Randomized trial of @entity1140 in combination with XXXX or @entity618 in kidney transplantation: results at 6 months.

@entity1 @entity407 @entity101 @entity6 @entity3446 @entity2098 @entity618 @entity1431 @entity1140 @entity1011 @entity288
BACKGROUND: This is the first report of a randomized, multicenter, clinical trial comparing the combination of @entity3446 or @entity618 ( @entity2098 ) with @entity1140 -based immunosuppression in kidney transplantation. Results at 6 months of follow-up are presented. METHODS: Before transplantation, @entity1 were randomized to receive @entity1140 plus @entity288 with @entity3446 (n=185) or @entity2098 (n=176). The primary endpoint of the study was the incidence of biopsy-confirmed acute rejection. @entity1 and graft survival, renal function, and composite endpoints also were evaluated. Safety was assessed by monitoring laboratory parameters and adverse events. RESULTS: By 6 months of follow-up, the incidence of biopsy-confirmed acute rejection was similar in both treatment groups (13.0% @entity1140 + @entity3446 vs. 11.4% @entity1140 + @entity2098 ; P=0.64 log-rank). @entity1 survival (97.3% @entity1140 + @entity3446 vs. 97.7% @entity1140 + @entity2098 ) and graft survival (93.0% @entity1140 + @entity3446 vs. 95.5% @entity1140 + @entity2098 ) were equivalent (P=0.53, overall survival log-rank). There was a significantly higher incidence of study drug discontinuation in @entity1 receiving @entity3446 (21.1% vs. 10.8%; P=0.008). Renal function was significantly better in the @entity2098 -treatment group (serum @entity1011 1.44+/-0.45 mg/dL vs. 1.77+/-1.42 mg/dL; P=0.018). @entity407 was significantly more prevalent in the @entity3446 -treatment group. Diastolic blood pressure was significantly higher in @entity3446 -treated @entity1 . There were significantly more @entity1431 and gastrointestinal adverse events in the @entity2098 -treatment group. The incidence of @entity6 was 7.6% in the @entity3446 group and 7.7% in the @entity2098 group. CONCLUSION: @entity1140 is equally effective in renal transplantation when combined with @entity3446 or @entity2098 . The @entity1140 - @entity2098 combination may be superior in terms of improved renal function and improved cardiovascular risk factors including @entity407 and @entity101 .
