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Long-term Safety Extension to Study TRCA-301

NCT03390842 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2021-10-22

Study results available
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Summary

This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.

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
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-20
Primary Completion
2019-02-22
Completion
2019-02-22
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • 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 NCT03390842 on ClinicalTrials.gov