Phase I trial of @entity6170 in XXXX : I. Report of the FONT Study Group.

@entity1 @entity8 @entity12585 @entity628 @entity740 @entity6170 @entity65
BACKGROUND AND OBJECTIVES: @entity1 with primary @entity628 ( @entity628 ) who are resistant to standard therapy are at high risk for progressive @entity740 . Prevention of @entity8 represents a promising strategy to slow or halt kidney function decline. This paper presents the results of a Phase I clinical trial of @entity6170 , a @entity12585 , that exerts antifibrotic effects in animal models of @entity628 . The primary goal was assessment of safety, tolerability, and pharmacokinetics (PK) of @entity6170 . DESIGN, SETTING, @entity1 , _ MEASUREMENTS: Eleven @entity1 , including eight @entity1 / @entity1 and three @entity1 / @entity1 , with mean age 15 +/- 6 yr and estimated GFR 131 +/- 62 ml/min/1.73 m(2), received @entity6170 , 3 mg/m(2)/d for 16 wk. PK was assessed twice, after the initial dose and after attaining steady state, in a General Clinical Research Center. RESULTS: There were no serious adverse events or @entity65 . @entity6170 was well tolerated by all @entity1 , as judged by the Treatment Satisfaction Questionnaire for Medication. The PK studies indicated that the area under the curve was decreased by 40 to 50% and oral clearance of @entity6170 was increased by 250 to 300% in @entity1 with resistant @entity628 compared with healthy controls and @entity1 with @entity740 . CONCLUSIONS: @entity6170 therapy was safe and well tolerated. PK assessment of potential novel therapies for resistant @entity628 is necessary to define appropriate dosing regimens. There is rationale to evaluate the efficacy of @entity6170 as an antifibrotic agent for resistant @entity628 in Phase II/III clinical trials.
