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Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis

NCT03710291 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1480

Last updated 2022-10-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.

Conditions

Interventions

DRUG

TRC101

Oral, non-absorbed, polymeric hydrochloric acid binder

DRUG

Placebo

Placebo comparator

Sponsors & Collaborators

  • Tricida, Inc.

    lead INDUSTRY

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
2018-11-20
Primary Completion
2022-08-23
Completion
2022-09-27
FDA Drug
Yes

Countries

  • United States
  • Albania
  • Argentina
  • Armenia
  • Australia
  • Belarus
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Czechia
  • France
  • Georgia
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • North Macedonia
  • Poland
  • Portugal
  • Romania
  • Serbia
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03710291 on ClinicalTrials.gov