MedTrace Logo

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

NCT03317444 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2021-04-26

Study results available
· View outcomes & findings →

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.

Conditions

  • Metabolic Acidosis

Interventions

DRUG

TRC101

Oral suspension

DRUG

Placebo

Oral suspension

Sponsors & Collaborators

  • Tricida, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Operations · Tricida, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-26
Primary Completion
2018-05-04
Completion
2018-05-15
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Croatia
  • Georgia
  • Hungary
  • Serbia
  • Slovenia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03317444 on ClinicalTrials.gov