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Long-term Safety Extension to Study TRCA-301

Primary Purpose

Metabolic Acidosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TRC101
Placebo
Sponsored by
Tricida, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Acidosis focused on measuring blood bicarbonate, kidney disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigative Site 55
  • Investigative Site 91
  • Investigative Site 59
  • Investigative Site 93
  • Investigative Site 92
  • Investigative Site 95
  • Investigative Site 52
  • Investigative Site 11
  • Investigative Site 31
  • Investigative Site 32
  • Investigative Site 33
  • Investigative Site 34
  • Investigative Site 35
  • Investigative Site 36
  • Investigative Site 37
  • Investigative Site 41
  • Investigative Site 46
  • Investigative Site 49
  • Investigative Site 44
  • Investigative Site 61
  • Investigative Site 72
  • Investigative Site 71
  • Investigative Site 81
  • Investigative Site 83
  • Investigative Site 87
  • Investigative Site 88
  • Investigative Site 84
  • Investigative Site 85
  • Investigative Site 86

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TRC101

Placebo

Arm Description

Administered once daily (QD) for 40 weeks

Administered once daily (QD) for 40 weeks

Outcomes

Primary Outcome Measures

Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal.
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

Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
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).
Change From Baseline in Serum Bicarbonate at the End of Treatment
Change from baseline in serum bicarbonate at the end of treatment (Week 52).
Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment
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.
Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment
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.

Full Information

First Posted
December 28, 2017
Last Updated
September 24, 2021
Sponsor
Tricida, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03390842
Brief Title
Long-term Safety Extension to Study TRCA-301
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
February 22, 2019 (Actual)
Study Completion Date
February 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tricida, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Acidosis
Keywords
blood bicarbonate, kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRC101
Arm Type
Experimental
Arm Description
Administered once daily (QD) for 40 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered once daily (QD) for 40 weeks
Intervention Type
Drug
Intervention Name(s)
TRC101
Other Intervention Name(s)
Veverimer
Intervention Description
Oral suspension
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral suspension
Primary Outcome Measure Information:
Title
Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal.
Description
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.
Time Frame
Week 12 Visit in the parent study, TRCA-301, to the Week 54 Visit in the extension study, TRCA-301E.
Secondary Outcome Measure Information:
Title
Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
Description
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).
Time Frame
Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
Title
Change From Baseline in Serum Bicarbonate at the End of Treatment
Description
Change from baseline in serum bicarbonate at the end of treatment (Week 52).
Time Frame
Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
Title
Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment
Description
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.
Time Frame
Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
Title
Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment
Description
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.
Time Frame
Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Operations
Organizational Affiliation
Tricida, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site 55
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Investigative Site 91
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Investigative Site 59
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Investigative Site 93
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Investigative Site 92
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Facility Name
Investigative Site 95
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Investigative Site 52
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Investigative Site 11
City
Sofia
Country
Bulgaria
Facility Name
Investigative Site 31
City
Tbilisi
Country
Georgia
Facility Name
Investigative Site 32
City
Tbilisi
Country
Georgia
Facility Name
Investigative Site 33
City
Tbilisi
Country
Georgia
Facility Name
Investigative Site 34
City
Tbilisi
Country
Georgia
Facility Name
Investigative Site 35
City
Tbilisi
Country
Georgia
Facility Name
Investigative Site 36
City
Tbilisi
Country
Georgia
Facility Name
Investigative Site 37
City
Tbilisi
Country
Georgia
Facility Name
Investigative Site 41
City
Budapest
Country
Hungary
Facility Name
Investigative Site 46
City
Budapest
Country
Hungary
Facility Name
Investigative Site 49
City
Hódmezővásárhely
Country
Hungary
Facility Name
Investigative Site 44
City
Kistarcsa
Country
Hungary
Facility Name
Investigative Site 61
City
Vršac
Country
Serbia
Facility Name
Investigative Site 72
City
Jesenice
Country
Slovenia
Facility Name
Investigative Site 71
City
Maribor
Country
Slovenia
Facility Name
Investigative Site 81
City
Kharkiv
Country
Ukraine
Facility Name
Investigative Site 83
City
Kharkiv
Country
Ukraine
Facility Name
Investigative Site 87
City
Kharkiv
Country
Ukraine
Facility Name
Investigative Site 88
City
Kharkiv
Country
Ukraine
Facility Name
Investigative Site 84
City
Kyiv
Country
Ukraine
Facility Name
Investigative Site 85
City
Kyiv
Country
Ukraine
Facility Name
Investigative Site 86
City
Kyiv
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31248662
Citation
Wesson DE, Mathur V, Tangri N, Stasiv Y, Parsell D, Li E, Klaerner G, Bushinsky DA. Long-term safety and efficacy of veverimer in patients with metabolic acidosis in chronic kidney disease: a multicentre, randomised, blinded, placebo-controlled, 40-week extension. Lancet. 2019 Aug 3;394(10196):396-406. doi: 10.1016/S0140-6736(19)31388-1. Epub 2019 Jun 24.
Results Reference
result
PubMed Identifier
35216581
Citation
Mathur VS, Wesson DE, Tangri N, Li E, Bushinsky DA. Effects of veverimer on serum bicarbonate and physical function in women with chronic kidney disease and metabolic acidosis: a subgroup analysis from a randomised, controlled trial. BMC Nephrol. 2022 Feb 25;23(1):82. doi: 10.1186/s12882-022-02690-1.
Results Reference
derived

Learn more about this trial

Long-term Safety Extension to Study TRCA-301

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