Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease

Summary

This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily. The maximum study duration is anticipated to be up to 16 weeks.

Timeline

Start

2017-09-26

Primary completion

2018-05-04

Completion

2018-05-15

Outcome

Met primary endpoint

registry TRC101 Treatment Arm vs Placebo Treatment Arm; p < 0.0001; Treatment difference in % of subjects 36.7 (95% CI 23.5 to 48.9) NCT03317444 ↗

paper The composite primary endpoint was met by 71 (59%) of 120 patients in the veverimer group versus 20 (22%) of 89 patients PMID 30857647 ↗

Publications

• Results Wesson DE, Mathur V, Tangri N, Stasiv Y, Parsell D, Li E, Klaerner G, Bushinsky DA. Veverimer versus placebo in patients with metabolic acidosis associated with chronic kidney disease: a multicentre, randomised, double-blind, controlled, phase 3 trial. Lancet. 2019 Apr 6;393(10179):1417-1427. doi: 10.1016/S0140-6736(18)32562-5. Epub 2019 Mar 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Veverimer	Other / unclassified	6 g	Oral

Indications