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Trial record 1 of 2 for:    TRCA-301
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Long-term Safety Extension to Study TRCA-301

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: NCT03390842
Recruitment Status : Completed
First Posted : January 4, 2018
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Tricida, Inc.

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
Actual Study Start Date : December 20, 2017
Actual Primary Completion Date : February 22, 2019
Actual Study Completion Date : February 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: TRC101
Administered once daily (QD) for 40 weeks
 Drug: TRC101
Oral suspension
Other Name: Veverimer
Placebo Comparator: Placebo
Administered once daily (QD) for 40 weeks
 Drug: Placebo
Oral suspension


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to withdrawal. [ Time Frame: From Week 12 (enrollment) to Week 54 (last follow-up visit). ]
    Safety.


Secondary Outcome Measures :
  1. Change from baseline in blood bicarbonate. [ Time Frame: Week 52 (end of treatment) ]
    Efficacy.


Eligibility Criteria
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Information from the National Library of Medicine

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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:

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

Key Exclusion Criteria:

  • Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
  • Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-301.
  • Planned initiation of renal replacement therapy within 6 months following study entry.
  • History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, severe gastrointestinal disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers.
  • Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.
Contacts and Locations
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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): NCT03390842


Locations
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Sponsors and Collaborators
Tricida, Inc.
More Information
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Publications of Results:

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Responsible Party: Tricida, Inc.
ClinicalTrials.gov Identifier: NCT03390842    
Other Study ID Numbers: TRCA-301E
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 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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Acidosis
Acid-Base Imbalance
Metabolic Diseases