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

Primary Purpose

Acidosis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Placebo
TRC101
Sponsored by
Tricida, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acidosis focused on measuring metabolic acidosis, serum bicarbonate, kidney disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) of 20 to <60 mL/min/1.73m2
  • Serum bicarbonate level of 12 to 20 mEq/L

Exclusion Criteria:

  • Any level of low serum bicarbonate that, in the opinion of the Investigator, requires emergency intervention.
  • Severe comorbid conditions other than chronic kidney disease.
  • Chronic obstructive pulmonary disease.
  • Anticipated changes in doses of any of the following drugs or drug classes: diuretics, non-ophthalmic carbonic anhydrase inhibitors, oral diabetes drugs, antihypertensive drugs, antacids, H2-blockers, or proton pump inhibitors.
  • Excluded drugs or drug classes: insulin, non-daily or "as needed" diuretics, herbal products, dietary supplements, multivitamins, naturopathic remedies, sodium bicarbonate, potassium citrate, sodium citrate or other alkali therapy, non-steroidal anti-inflammatory drugs (NSAIDs), fiber supplements, laxatives, calcium and magnesium supplements, or electrolyte binders and other binder drugs.

Sites / Locations

  • Investigative Site 1
  • Investigative Site 3
  • Investigative Site 4
  • Investigative Site 5
  • Investigative Site 6

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Placebo-BID

TRC101 (1.5g BID)

TRC101 (3g BID)

TRC101 (4.5g BID)

TRC101 (6g QD)

Placebo-QD

Arm Description

Administered twice daily (BID) for 14 days

Administered twice daily (BID) for 14 days

Administered twice daily (BID) for 14 days

Administered twice daily (BID) for 14 days

Administered once daily (QD) for 14 days

Administered once daily (QD) for 14 days

Outcomes

Primary Outcome Measures

Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE
The number and percentage of subjects who reported treatment-emergent adverse events (TEAEs) summarized by system organ class and preferred term (see Reported Adverse Events) as well as by severity, causality, seriousness, and action taken with regard to study drug. All analyses were descriptive.
Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline

Secondary Outcome Measures

Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for each TRC101 dose group versus that for Placebo
Change From Baseline in Serum Bicarbonate at Day 15 Within the Combined TRC101 Treatment Group
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline
Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between the Combined TRC101 Treatment Group Versus Placebo
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the Combined TRC101 Treatment Group versus that for Placebo
Comparison of the Proportion of Subjects Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Between Each TRC101 Dose Group Versus Placebo
Comparison of the proportion of subjects whose serum bicarbonate values increased from Baseline to Day 15 by greater than or equal to 2, 3, or 4 mEq/L between each TRC101 BID Dose Group versus Placebo
Change From Baseline in Serum Bicarbonate at Day 15 Within the TRC101 6g QD Dose Group
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline
Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus Placebo
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the TRC101 6g dose group versus that for Placebo
Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus the TRC101 3g BID Dose Group
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the TRC101 6g QD dose group versus that for the TRC101 3g BID dose group
Comparison of the Proportion of Subjects in the TRC101 6g QD Dose Group Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Versus Placebo
Comparison of the proportion of subjects whose serum bicarbonate values increased from Baseline to Day 15 by greater than or equal to 2, 3, or 4 mEq/L between the 6g TRC101 QD Dose Group versus Placebo

Full Information

First Posted
June 14, 2016
Last Updated
January 2, 2020
Sponsor
Tricida, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02809183
Brief Title
Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
Official Title
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of TRC101 in Subjects With Chronic Kidney Disease and Low Serum Bicarbonate Levels
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (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
No

5. Study Description

Brief Summary
This was a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The study enrolled 135 adult male and female subjects with Stage 3 or 4 chronic kidney disease and low serum bicarbonate levels. The study was conducted in two parts. In Part 1 study drug dosing (TRC101 or placebo) continued for 14 days twice daily (BID). In Part 2 study drug dosing (TRC101 or placebo) continued for 14 days once daily (QD). The maximum study duration per subject was anticipated to be up to 42 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acidosis
Keywords
metabolic acidosis, serum bicarbonate, kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo-BID
Arm Type
Placebo Comparator
Arm Description
Administered twice daily (BID) for 14 days
Arm Title
TRC101 (1.5g BID)
Arm Type
Experimental
Arm Description
Administered twice daily (BID) for 14 days
Arm Title
TRC101 (3g BID)
Arm Type
Experimental
Arm Description
Administered twice daily (BID) for 14 days
Arm Title
TRC101 (4.5g BID)
Arm Type
Experimental
Arm Description
Administered twice daily (BID) for 14 days
Arm Title
TRC101 (6g QD)
Arm Type
Experimental
Arm Description
Administered once daily (QD) for 14 days
Arm Title
Placebo-QD
Arm Type
Placebo Comparator
Arm Description
Administered once daily (QD) for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral suspension
Intervention Type
Drug
Intervention Name(s)
TRC101
Other Intervention Name(s)
Veverimer
Intervention Description
oral suspension
Primary Outcome Measure Information:
Title
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE
Description
The number and percentage of subjects who reported treatment-emergent adverse events (TEAEs) summarized by system organ class and preferred term (see Reported Adverse Events) as well as by severity, causality, seriousness, and action taken with regard to study drug. All analyses were descriptive.
Time Frame
Through treatment period completion (Day 15)
Title
Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group
Description
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline
Time Frame
Baseline and Day 15
Secondary Outcome Measure Information:
Title
Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo
Description
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for each TRC101 dose group versus that for Placebo
Time Frame
Baseline and Day 15
Title
Change From Baseline in Serum Bicarbonate at Day 15 Within the Combined TRC101 Treatment Group
Description
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline
Time Frame
Baseline and Day 15
Title
Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between the Combined TRC101 Treatment Group Versus Placebo
Description
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the Combined TRC101 Treatment Group versus that for Placebo
Time Frame
Baseline and Day 15
Title
Comparison of the Proportion of Subjects Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Between Each TRC101 Dose Group Versus Placebo
Description
Comparison of the proportion of subjects whose serum bicarbonate values increased from Baseline to Day 15 by greater than or equal to 2, 3, or 4 mEq/L between each TRC101 BID Dose Group versus Placebo
Time Frame
Baseline and Day 15
Title
Change From Baseline in Serum Bicarbonate at Day 15 Within the TRC101 6g QD Dose Group
Description
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline
Time Frame
Baseline and Day 15
Title
Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus Placebo
Description
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the TRC101 6g dose group versus that for Placebo
Time Frame
Baseline and Day 15
Title
Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus the TRC101 3g BID Dose Group
Description
Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the TRC101 6g QD dose group versus that for the TRC101 3g BID dose group
Time Frame
Baseline and Day 15
Title
Comparison of the Proportion of Subjects in the TRC101 6g QD Dose Group Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Versus Placebo
Description
Comparison of the proportion of subjects whose serum bicarbonate values increased from Baseline to Day 15 by greater than or equal to 2, 3, or 4 mEq/L between the 6g TRC101 QD Dose Group versus Placebo
Time Frame
Baseline and Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Estimated glomerular filtration rate (eGFR) of 20 to <60 mL/min/1.73m2 Serum bicarbonate level of 12 to 20 mEq/L Exclusion Criteria: Any level of low serum bicarbonate that, in the opinion of the Investigator, requires emergency intervention. Severe comorbid conditions other than chronic kidney disease. Chronic obstructive pulmonary disease. Anticipated changes in doses of any of the following drugs or drug classes: diuretics, non-ophthalmic carbonic anhydrase inhibitors, oral diabetes drugs, antihypertensive drugs, antacids, H2-blockers, or proton pump inhibitors. Excluded drugs or drug classes: insulin, non-daily or "as needed" diuretics, herbal products, dietary supplements, multivitamins, naturopathic remedies, sodium bicarbonate, potassium citrate, sodium citrate or other alkali therapy, non-steroidal anti-inflammatory drugs (NSAIDs), fiber supplements, laxatives, calcium and magnesium supplements, or electrolyte binders and other binder drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuri Stasiv, PhD
Organizational Affiliation
Tricida, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site 1
City
Sofia
Country
Bulgaria
Facility Name
Investigative Site 3
City
Tbilisi
Country
Georgia
Facility Name
Investigative Site 4
City
Tbilisi
Country
Georgia
Facility Name
Investigative Site 5
City
Tbilisi
Country
Georgia
Facility Name
Investigative Site 6
City
Tbilisi
Country
Georgia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29102959
Citation
Bushinsky DA, Hostetter T, Klaerner G, Stasiv Y, Lockey C, McNulty S, Lee A, Parsell D, Mathur V, Li E, Buysse J, Alpern R. Randomized, Controlled Trial of TRC101 to Increase Serum Bicarbonate in Patients with CKD. Clin J Am Soc Nephrol. 2018 Jan 6;13(1):26-35. doi: 10.2215/CJN.07300717. Epub 2017 Nov 4. Erratum In: Clin J Am Soc Nephrol. 2019 Feb 7;14(2):277.
Results Reference
result

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

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