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

April 23, 2021 updated by: Tricida, Inc.

A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria
        • Investigative Site 11
  • Croatia
      • Zagreb, Croatia
        • Investigative Site 21
  • Georgia
      • Tbilisi, Georgia
        • Investigative Site 31
      • Tbilisi, Georgia
        • Investigative Site 32
      • Tbilisi, Georgia
        • Investigative Site 33
      • Tbilisi, Georgia
        • Investigative Site 34
      • Tbilisi, Georgia
        • Investigative Site 35
      • Tbilisi, Georgia
        • Investigative Site 36
      • Tbilisi, Georgia
        • Investigative Site 37
  • Hungary
      • Baja, Hungary
        • Investigative Site 43
      • Balatonfüred, Hungary
        • Investigative Site 48
      • Budapest, Hungary
        • Investigative Site 41
      • Budapest, Hungary
        • Investigative Site 46
      • Hatvan, Hungary
        • Investigative Site 45
      • Hódmezővásárhely, Hungary
        • Investigative Site 49
      • Kistarcsa, Hungary
        • Investigative Site 44
      • Miskolc, Hungary
        • Investigative Site 42
      • Mosonmagyaróvár, Hungary
        • Investigative Site 47
  • Serbia
      • Belgrade, Serbia
        • Investigative Site 64
      • Belgrade, Serbia
        • Investigative Site 65
      • Vršac, Serbia
        • Investigative Site 61
      • Zrenjanin, Serbia
        • Investigative Site 62
  • Slovenia
      • Jesenice, Slovenia
        • Investigative Site 72
      • Maribor, Slovenia
        • Investigative Site 71
  • Ukraine
      • Kharkiv, Ukraine
        • Investigative Site 81
      • Kharkiv, Ukraine
        • Investigative Site 83
      • Kharkiv, Ukraine
        • Investigative Site 87
      • Kharkiv, Ukraine
        • Investigative Site 88
      • Kyiv, Ukraine
        • Investigative Site 84
      • Kyiv, Ukraine
        • Investigative Site 85
      • Kyiv, Ukraine
        • Investigative Site 86
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Investigative Site 55
    • California
      • Chula Vista, California, United States, 91910
        • Investigative Site 56
      • Los Angeles, California, United States, 90022
        • Investigative Site 91
    • Florida
      • Hialeah, Florida, United States, 33015
        • Investigative Site 59
      • Hollywood, Florida, United States, 33021
        • Investigative Site 54
      • Hollywood, Florida, United States, 33024
        • Investigative Site 93
      • Lauderdale Lakes, Florida, United States, 33313
        • Investigative Site 92
      • Tampa, Florida, United States, 33614
        • Investigative Site 51
      • Winter Park, Florida, United States, 32789
        • Investigative Site 57
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Investigative Site 95
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Investigative Site 53
    • New York
      • Flushing, New York, United States, 11355
        • Investigative Site 58
    • Texas
      • San Antonio, Texas, United States, 78215
        • Investigative Site 52

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Blood bicarbonate level of 12 to 20 mEq/L.
  • Estimated glomerular filtration rate (eGFR) of 20 to 40 mL/min/1.73m2.
  • Stable kidney function defined as <=20% variability in eGFR during screening period.

Key Exclusion Criteria:

  • Any level of low blood bicarbonate during the screening period that in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
  • Anuria, dialysis, acute kidney injury, or history of acute kidney insufficiency within 3 months prior to screening.
  • Heart failure with maximum New York Heart Association (NYHA) Class IV symptoms or that required hospitalization during the preceding 6 months.
  • Heart or kidney transplant.
  • Chronic obstructive pulmonary disease (COPD) that is treated with chronic oral steroids, that requires the subject to be on oxygen, or that required hospitalization within the previous 6 months.
  • Change in doses to alkali therapy in the 4 weeks prior to screening.
  • History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, inflammatory bowel disease, major gastrointestinal surgery, frequent diarrhea or active gastric/duodenal ulcers.
  • Serum calcium <= 8.0 mg/dL at screening.
  • Planned initiation of renal replacement therapy within 12 weeks following randomization.
  • Use of polymeric binder drugs within 14 days prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRC101
Administered once daily (QD) for 12 weeks
Drug: TRC101
Oral suspension
Other Names:
  • Veverimer
Placebo Comparator: Placebo
Administered once daily (QD) for 12 weeks
Drug: Placebo
Oral suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
Time Frame: Baseline to Week 12
Composite endpoint of the percentage of subjects having a change from baseline in serum bicarbonate ≥ 4 mEq/L or having serum bicarbonate in the normal range (22 - 29 mEq/L) at the end of treatment (Week 12 Visit).
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to End of Treatment in Serum Bicarbonate
Time Frame: Baseline to Week 12
Mean change from baseline to end of treatment (Week 12 Visit) in serum bicarbonate
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tricida, Inc.

Investigators

  • Study Director: Clinical Operations, Tricida, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2017

Primary Completion (Actual)

May 4, 2018

Study Completion (Actual)

May 15, 2018

Study Registration Dates

First Submitted

October 11, 2017

First Submitted That Met QC Criteria

October 19, 2017

First Posted (Actual)

October 23, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRCA-301
  • 2016-003825-41 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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