Long-term Safety Extension to Study TRCA-301

Last updated: September 24, 2021
Sponsor: Tricida, Inc.
Overall Status: Completed

Phase

3

Condition

Arginase Deficiency

Metabolic Disorders

Distal Renal Tubular Acidosis

Treatment

N/A

Clinical Study ID

NCT03390842
TRCA-301E
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Completed the 12-week treatment period and attended the Week 12 Visit in the parentstudy TRCA-301.
  • Blood bicarbonate level of >= 12 mEq/L at the Week 12 Visit in the parent studyTRCA-301.

Exclusion

Key Exclusion Criteria:

  • Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of theInvestigator, requires emergency intervention or evaluation for an acute acidoticprocess.
  • Required dialysis for acute kidney injury or worsening CKD during the parent studyTRCA-301.
  • Planned initiation of renal replacement therapy within 6 months following study entry.
  • History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowingdisorders, severe gastrointestinal disorders, inflammatory bowel disease, majorgastrointestinal surgery, or active gastric/duodenal ulcers.
  • Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.

Study Design

Total Participants: 196
Study Start date:
December 20, 2017
Estimated Completion Date:
February 22, 2019

Connect with a study center

  • Investigative Site 11

    Sofia,
    Bulgaria

    Site Not Available

  • Investigative Site 31

    Tbilisi,
    Georgia

    Site Not Available

  • Investigative Site 32

    Tbilisi,
    Georgia

    Site Not Available

  • Investigative Site 33

    Tbilisi,
    Georgia

    Site Not Available

  • Investigative Site 34

    Tbilisi,
    Georgia

    Site Not Available

  • Investigative Site 35

    Tbilisi,
    Georgia

    Site Not Available

  • Investigative Site 36

    Tbilisi,
    Georgia

    Site Not Available

  • Investigative Site 37

    Tbilisi,
    Georgia

    Site Not Available

  • Investigative Site 41

    Budapest,
    Hungary

    Site Not Available

  • Investigative Site 46

    Budapest,
    Hungary

    Site Not Available

  • Investigative Site 49

    Hódmezővásárhely,
    Hungary

    Site Not Available

  • Investigative Site 44

    Kistarcsa,
    Hungary

    Site Not Available

  • Investigative Site 61

    Vršac,
    Serbia

    Site Not Available

  • Investigative Site 72

    Jesenice,
    Slovenia

    Site Not Available

  • Investigative Site 71

    Maribor,
    Slovenia

    Site Not Available

  • Investigative Site 81

    Kharkiv,
    Ukraine

    Site Not Available

  • Investigative Site 83

    Kharkiv,
    Ukraine

    Site Not Available

  • Investigative Site 87

    Kharkiv,
    Ukraine

    Site Not Available

  • Investigative Site 88

    Kharkiv,
    Ukraine

    Site Not Available

  • Investigative Site 84

    Kyiv,
    Ukraine

    Site Not Available

  • Investigative Site 85

    Kyiv,
    Ukraine

    Site Not Available

  • Investigative Site 86

    Kyiv,
    Ukraine

    Site Not Available

  • Investigative Site 55

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Investigative Site 56

    Chula Vista, California 91910
    United States

    Site Not Available

  • Investigative Site 91

    Los Angeles, California 90022
    United States

    Site Not Available

  • Investigative Site 59

    Hialeah, Florida 33015
    United States

    Site Not Available

  • Investigative Site 93

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Investigative Site 92

    Lauderdale Lakes, Florida 33313
    United States

    Site Not Available

  • Investigative Site 57

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Investigative Site 95

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Investigative Site 52

    San Antonio, Texas 78215
    United States

    Site Not Available

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