For maintenance treatment, the initial dose of LOKELMA was 5 g qd and was adjusted to a minimum of 5 g qod up to a maximum of 15 g qd, based on i-STAT K + level. Following the initial-phase treatment of LOKELMA 10 g tid, patients who achieved normokalemia * within 72 hours (n=746 99%) entered the maintenance phase. STUDY 3 DESIGN: LOKELMA was evaluated for long-term efficacy in 751 patients with hyperkalemia in an open-label, single-arm, 12-month, phase 3 study. The LOKELMA dose was titrated in 5-g increments (to 5 g qod up to 15 g qd) based on i-STAT K + levels. STUDY 2 EXTENSION DESIGN: Patients who were included in the 28-day randomized maintenance phase of Study 2 had the option to continue treatment with LOKELMA in an open-label extension phase for up to 11 months (N=123). 123 patients who completed the maintenance phase participated in the 11-month, open-label extension study. STUDY 2 DESIGN: After the open-label initial phase of a multicenter, 2-part, phase 3 trial, in which 258 patients received 10 g LOKELMA tid for 48 hours, patients who achieved a K + level between 3.5 and 5.0 mEq/L were randomized to receive 5 g, 10 g, or 15 g LOKELMA or placebo once daily for 28 days in the maintenance phase. STUDY 1 DESIGN: In the initial phase of a multicenter, 2-part, double-blind, randomized, placebo-controlled, phase 3 trial, 753 patients received placebo or 1.25 g, 2.5 g, 5 g, or 10 g LOKELMA tid for the initial 48 hours.
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