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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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.


Condition or disease Intervention/treatment Phase
Metabolic Acidosis Drug: TRC101 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 26, 2017
Actual Primary Completion Date : May 4, 2018
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: TRC101
Administered once daily (QD) for 12 weeks
Drug: TRC101
Oral suspension
Other Name: Veverimer

Placebo Comparator: Placebo
Administered once daily (QD) for 12 weeks
Drug: Placebo
Oral suspension




Primary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317444


Locations
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Sponsors and Collaborators
Tricida, Inc.
Investigators
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Study Director: Yuri Stasiv, PhD Tricida, Inc.
Publications of Results:
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Responsible Party: Tricida, Inc.
ClinicalTrials.gov Identifier: NCT03317444    
Other Study ID Numbers: TRCA-301
2016-003825-41 ( EudraCT Number )
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tricida, Inc.:
blood bicarbonate, kidney disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acidosis
Urologic Diseases
Renal Insufficiency
Acid-Base Imbalance
Metabolic Diseases