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Trial record 2 of 2 for:    TRCA-301

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

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ClinicalTrials.gov Identifier: NCT03317444
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Tricida, Inc.

Tracking Information
First Submitted Date  ICMJE October 11, 2017
First Posted Date  ICMJE October 23, 2017
Last Update Posted Date March 26, 2019
Actual Study Start Date  ICMJE September 26, 2017
Actual Primary Completion Date May 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2017)
Change from baseline in blood bicarbonate. [ Time Frame: Week 12 ]
Comparison of TRC101 and placebo with regard to the proportions of subjects with change from baseline in blood bicarbonate ≥ 4 mEq/L or with blood bicarbonate in the normal range (22 to 29 mEq/L).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: October 19, 2017)
Adverse events, serious adverse events, withdrawal of treatment due to an adverse event. [ Time Frame: Up to Week 14 ]
Number and percentage of subjects with treatment-emergent adverse events (TEAEs), number and percentage of subjects experiencing TEAEs by severity, causality, seriousness, and action taken with regard to study drug by treatment group. TEAEs leading to discontinuation of study treatment will be summarized by treatment group.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Acidosis
Intervention  ICMJE
  • Drug: TRC101
    Oral suspension
    Other Name: Veverimer
  • Drug: Placebo
    Oral suspension
Study Arms  ICMJE
  • Experimental: TRC101
    Administered once daily (QD) for 12 weeks
    Intervention: Drug: TRC101
  • Placebo Comparator: Placebo
    Administered once daily (QD) for 12 weeks
    Intervention: Drug: Placebo
Publications * Wesson DE, Mathur V, Tangri N, Stasiv Y, Parsell D, Li E, Klaerner G, Bushinsky DA. Veverimer versus placebo in patients with metabolic acidosis associated with chronic kidney disease: a multicentre, randomised, double-blind, controlled, phase 3 trial. Lancet. 2019 Apr 6;393(10179):1417-1427. doi: 10.1016/S0140-6736(18)32562-5. Epub 2019 Mar 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2018)
217
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2017)
210
Actual Study Completion Date  ICMJE May 15, 2018
Actual Primary Completion Date May 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Croatia,   Georgia,   Hungary,   Serbia,   Slovenia,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03317444
Other Study ID Numbers  ICMJE TRCA-301
2016-003825-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tricida, Inc.
Study Sponsor  ICMJE Tricida, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yuri Stasiv, PhD Tricida, Inc.
PRS Account Tricida, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP