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A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis
A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis
Status:Recruiting
Phase of Trial:
Phase III
Latest Information Update:14 Dec 2020
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08 Dec 2020
According to a Tricida media release, in response to feedback from the U.S. Food and Drug Administration (FDA) at the End-of-Review Type A Meeting, recruitment has been closed in all regions except for the United States, Canada and Western Europe. Recruitment completion is projected to occur by the end of 2022.
08 Dec 2020
According to a Tricida media release, The interim analyses will be conducted by an independent unblinded Interim Analysis Committee, and the trial will remain blinded unless it is stopped early for efficacy. As of December 7, 2020, trial has randomized 1,277 subjects with an average treatment duration of approximately one year and has accrued 50 of the 511 required subjects with positively adjudicated primary endpoint events.
08 Dec 2020
According to a Tricida media release, the protocol has been revised and has a group sequential design, no interim analysis for sample size adjustment, and unblinded interim analyses for early stopping for efficacy after 150 primary endpoint events (anticipated in the second half of 2021) and 250 primary endpoint events (anticipated in mid-2022) have accrued.
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