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

Tricida, Inc.135 enrolled

Overview

This was a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The study enrolled 135 adult male and female subjects with Stage 3 or 4 chronic kidney disease and low serum bicarbonate levels. The study was conducted in two parts. In Part 1 study drug dosing (TRC101 or placebo) continued for 14 days twice daily (BID). In Part 2 study drug dosing (TRC101 or placebo) continued for 14 days once daily (QD). The maximum study duration per subject was anticipated to be up to 42 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

135

Conditions

Acidosis

Interventions

PlaceboDRUG

oral suspension

TRC101DRUG

oral suspension

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Estimated glomerular filtration rate (eGFR) of 20 to \<60 mL/min/1.73m2 * Serum bicarbonate level of 12 to 20 mEq/L Exclusion Criteria: * Any level of low serum bicarbonate that, in the opinion of the Investigator, requires emergency intervention. * Severe comorbid conditions other than chronic kidney disease. * Chronic obstructive pulmonary disease. * Anticipated changes in doses of any of the following drugs or drug classes: diuretics, non-ophthalmic carbonic anhydrase inhibitors, oral diabetes drugs, antihypertensive drugs, antacids, H2-blockers, or proton pump inhibitors. * Excluded drugs or drug classes: insulin, non-daily or "as needed" diuretics, herbal products, dietary supplements, multivitamins, naturopathic remedies, sodium bicarbonate, potassium citrate, sodium citrate or other alkali therapy, non-steroidal anti-inflammatory drugs (NSAIDs), fiber supplements, laxatives, calcium and magnesium supplements, or electrolyte binders and other binder drugs.

Locations (5)

Investigative Site 1

Sofia, Bulgaria

Investigative Site 3

Tbilisi, Georgia

Investigative Site 4

Tbilisi, Georgia

Investigative Site 5

Tbilisi, Georgia

Investigative Site 6

Tbilisi, Georgia

Outcomes

Primary Outcomes

Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE

The number and percentage of subjects who reported treatment-emergent adverse events (TEAEs) summarized by system organ class and preferred term (see Reported Adverse Events) as well as by severity, causality, seriousness, and action taken with regard to study drug. All analyses were descriptive.

Time frame: Through treatment period completion (Day 15)

Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group

Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline

Time frame: Baseline and Day 15

Secondary Outcomes

Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo

Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for each TRC101 dose group versus that for Placebo

Time frame: Baseline and Day 15

Change From Baseline in Serum Bicarbonate at Day 15 Within the Combined TRC101 Treatment Group

Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline

Time frame: Baseline and Day 15

Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between the Combined TRC101 Treatment Group Versus Placebo

Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the Combined TRC101 Treatment Group versus that for Placebo

Time frame: Baseline and Day 15

Comparison of the Proportion of Subjects Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Between Each TRC101 Dose Group Versus Placebo

Data from ClinicalTrials.gov

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