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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
Results First Posted : October 22, 2021
Last Update Posted : October 22, 2021
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, Serious Adverse Events, and Adverse Events Leading to Withdrawal. [ Time Frame: Week 12 Visit in the parent study, TRCA-301, to the Week 54 Visit in the extension study, TRCA-301E. ]
    The incidence of adverse events (AEs), serious adverse events (SAEs) and AEs leading to withdrawal. For incidence of AEs and SAEs, see Adverse Events Section. For incidence of AEs leading to withdrawal, see endpoint values below.


Secondary Outcome Measures :
  1. Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range [ Time Frame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E. ]
    Percent of subjects having a change from baseline in serum bicarbonate of at least 4 mEq/L or bicarbonate in the normal range (22 - 29 mEq/L) at the end of treatment (Week 52).

  2. Change From Baseline in Serum Bicarbonate at the End of Treatment [ Time Frame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E. ]
    Change from baseline in serum bicarbonate at the end of treatment (Week 52).

  3. Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment [ Time Frame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E. ]
    Change from baseline in the total score of the Kidney Disease Quality of Life Physical Function Domain (KDQOL-PFD) at the end of treatment. The KDQOL is a validated, kidney disease-specific measure of health-related quality of life. For study TRCA-301E, and the parent study TRCA-301, the 10-question Item 3 of the KDQOL, also known as the SF-36 Physical Function subscale, was selected to measure physical functioning and is referenced herein as the KDQOL-PFD. The KDQOL-PFD was chosen as a patient-reported outcome measurement to evaluate the effects of TRC101 on daily activities that may be adversely affected by loss of muscle caused by metabolic acidosis. The minimum score for each of the 10 questions is 0 (physical activity highly limited) and the maximum is 100 (physical activity not limited). The total KDQOL-PFD score is calculated by adding the scores for all 10 questions, for a minimum and maximum possible total KDQOL-PFD score of 0 or 100, respectively.

  4. Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment [ Time Frame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E. ]
    Change from baseline in the duration of repeated chair stand test at the end of treatment (Week 52). The five-times repeated chair stand test was used as a measure of lower extremity muscle strength. In this test, the time it took for a subject to repeatedly stand from a chair five times was recorded. This test is among the group of measures (gait speed, chair stand, and balance tests) comprising the Short Physical Performance Battery (SPPB), which has been used as a predictive tool for possible disability and for monitoring physical functioning in older people.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
Investigators
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Study Director: Clinical Operations Tricida, Inc.
  Study Documents (Full-Text)

Documents provided by Tricida, Inc.:
Study Protocol  [PDF] October 17, 2018
Statistical Analysis Plan  [PDF] February 12, 2019

More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Results First Posted: October 22, 2021
Last Update Posted: October 22, 2021
Last Verified: September 2021
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