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

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:

  • 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.

Sites / Locations

  • Investigative Site 55
  • Investigative Site 56
  • Investigative Site 91
  • Investigative Site 59
  • Investigative Site 54
  • Investigative Site 93
  • Investigative Site 92
  • Investigative Site 51
  • Investigative Site 57
  • Investigative Site 95
  • Investigative Site 53
  • Investigative Site 58
  • Investigative Site 52
  • Investigative Site 11
  • Investigative Site 21
  • Investigative Site 31
  • Investigative Site 32
  • Investigative Site 33
  • Investigative Site 34
  • Investigative Site 35
  • Investigative Site 36
  • Investigative Site 37
  • Investigative Site 43
  • Investigative Site 48
  • Investigative Site 41
  • Investigative Site 46
  • Investigative Site 45
  • Investigative Site 49
  • Investigative Site 44
  • Investigative Site 42
  • Investigative Site 47
  • Investigative Site 64
  • Investigative Site 65
  • Investigative Site 61
  • Investigative Site 62
  • 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 12 weeks

Administered once daily (QD) for 12 weeks

Outcomes

Primary Outcome Measures

Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
Composite endpoint of the percentage of subjects having a change from baseline in serum bicarbonate ≥ 4 mEq/L or having serum bicarbonate in the normal range (22 - 29 mEq/L) at the end of treatment (Week 12 Visit).

Secondary Outcome Measures

Change From Baseline to End of Treatment in Serum Bicarbonate
Mean change from baseline to end of treatment (Week 12 Visit) in serum bicarbonate

Full Information

First Posted
October 11, 2017
Last Updated
April 23, 2021
Sponsor
Tricida, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03317444
Brief Title
Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 26, 2017 (Actual)
Primary Completion Date
May 4, 2018 (Actual)
Study Completion Date
May 15, 2018 (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 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.

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 ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRC101
Arm Type
Experimental
Arm Description
Administered once daily (QD) for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered once daily (QD) for 12 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
Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
Description
Composite endpoint of the percentage of subjects having a change from baseline in serum bicarbonate ≥ 4 mEq/L or having serum bicarbonate in the normal range (22 - 29 mEq/L) at the end of treatment (Week 12 Visit).
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline to End of Treatment in Serum Bicarbonate
Description
Mean change from baseline to end of treatment (Week 12 Visit) in serum bicarbonate
Time Frame
Baseline to Week 12

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: 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.
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 56
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
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 54
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
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 51
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Investigative Site 57
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Investigative Site 95
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Investigative Site 53
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Investigative Site 58
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
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 21
City
Zagreb
Country
Croatia
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 43
City
Baja
Country
Hungary
Facility Name
Investigative Site 48
City
Balatonfüred
Country
Hungary
Facility Name
Investigative Site 41
City
Budapest
Country
Hungary
Facility Name
Investigative Site 46
City
Budapest
Country
Hungary
Facility Name
Investigative Site 45
City
Hatvan
Country
Hungary
Facility Name
Investigative Site 49
City
Hódmezővásárhely
Country
Hungary
Facility Name
Investigative Site 44
City
Kistarcsa
Country
Hungary
Facility Name
Investigative Site 42
City
Miskolc
Country
Hungary
Facility Name
Investigative Site 47
City
Mosonmagyaróvár
Country
Hungary
Facility Name
Investigative Site 64
City
Belgrade
Country
Serbia
Facility Name
Investigative Site 65
City
Belgrade
Country
Serbia
Facility Name
Investigative Site 61
City
Vršac
Country
Serbia
Facility Name
Investigative Site 62
City
Zrenjanin
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
30857647
Citation
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.
Results Reference
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Learn more about this trial

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

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