A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of TRC101 in Subjects With Chronic Kidney Disease and Low Serum Bicarbonate Levels
Phase of Trial: Phase I/II
Latest Information Update: 02 Mar 2018
At a glance
- Drugs TRC 101 (Primary)
- Indications Acidosis; Kidney disorders; Renal failure
- Focus Adverse reactions; First in man
- Sponsors Tricida
- 02 Mar 2018 According to a Tricida media release, the results of this and another phase III trial (see CT 280722) are intended to serve as the basis for the submission of a U.S. New Drug Application (NDA) for TRC101 under the Accelerated Approval Program of the U.S. Food and Drug Administration (FDA).
- 08 Nov 2017 According to a Tricida media release, the results of this trial have been published in the Clinical Journal of the American Society of Nephrology (CJASN).
- 01 Nov 2017 According to Tricida media release, data from this trial will be presented at ASN Kidney Week 2017 .
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History