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

NCT02809183 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2020-01-14

Study results available
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Summary

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.

Conditions

  • Acidosis

Interventions

DRUG

Placebo

oral suspension

DRUG

TRC101

oral suspension

Sponsors & Collaborators

  • Tricida, Inc.

    lead INDUSTRY

Principal Investigators

  • Yuri Stasiv, PhD · Tricida, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-11-30
Completion
2016-11-30
FDA Drug
Yes

Countries

  • Bulgaria
  • Georgia

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 NCT02809183 on ClinicalTrials.gov