Trial · NCT02809183

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

NCT02809183, Phase 1, Phase 2, Completed, Tricida, Inc.; results first posted 2020-01-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis. Trials, record NCT02809183. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02809183

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
NCT number: NCT02809183
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 135 participants, actual
Lead sponsor: Tricida, Inc.
Conditions: Acidosis
Interventions: Placebo, TRC101
First posted: 2016-06-22
Last updated: 2020-01-14
Other registries' IDs: eudract:2015-004327-31
Results first posted: 2020-01-14

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE	Through treatment period completion (Day 15)	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.
Primary	Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group	Baseline and Day 15	Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline
Secondary	Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo	Baseline and Day 15	Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for each TRC101 dose group versus that for Placebo
Secondary	Change From Baseline in Serum Bicarbonate at Day 15 Within the Combined TRC101 Treatment Group	Baseline and Day 15	Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline
Secondary	Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between the Combined TRC101 Treatment Group Versus Placebo	Baseline and Day 15	Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the Combined TRC101 Treatment Group versus that for Placebo
Secondary	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	Baseline and Day 15	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
Secondary	Change From Baseline in Serum Bicarbonate at Day 15 Within the TRC101 6g QD Dose Group	Baseline and Day 15	Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline
Secondary	Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus Placebo	Baseline and Day 15	Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the TRC101 6g dose group versus that for Placebo
Secondary	Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus the TRC101 3g BID Dose Group	Baseline and Day 15	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
Secondary	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	Baseline and Day 15	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

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE	Through treatment period completion (Day 15)	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group	Baseline and Day 15	Full Analysis Set	mEq/L	LEAST_SQUARES_MEAN
SECONDARY	Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo	Baseline and Day 15	Full Analysis Set	mEq/L	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Serum Bicarbonate at Day 15 Within the Combined TRC101 Treatment Group	Baseline and Day 15	Full Analysis Set	mEq/L	LEAST_SQUARES_MEAN
SECONDARY	Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between the Combined TRC101 Treatment Group Versus Placebo	Baseline and Day 15	Full Analysis Set	mEq/L	LEAST_SQUARES_MEAN
SECONDARY	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	Baseline and Day 15	Full Analysis Set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Serum Bicarbonate at Day 15 Within the TRC101 6g QD Dose Group	Baseline and Day 15	Full Analysis Set	mEq/L	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus Placebo	Baseline and Day 15	Full Analysis Set	mEq/L	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus the TRC101 3g BID Dose Group	Baseline and Day 15	Full Analysis Set	mEq/L	LEAST_SQUARES_MEAN
SECONDARY	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	Baseline and Day 15	Full Analysis Set	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group64

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE	Pooled Placebo	Subjects Reporting any TEAE	14	Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE	1.5g TRC101 BID	Subjects Reporting any TEAE	13	Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE	3g TRC101 BID	Subjects Reporting any TEAE	9	Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE	4.5g TRC101 BID	Subjects Reporting any TEAE	17	Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE	6g TRC101 QD	Subjects Reporting any TEAE	17	Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE	Pooled Placebo	≥ 1 Mild TEAE	11	Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE	1.5g TRC101 BID	≥ 1 Mild TEAE	9	Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE	3g TRC101 BID	≥ 1 Mild TEAE	8	Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE	4.5g TRC101 BID	≥ 1 Mild TEAE	14	Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE	6g TRC101 QD	≥ 1 Mild TEAE	15	Participants

1 to 10 of 64Source ClinicalTrials.gov

See all 64 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo BID	25
Overall Study	STARTED	1.5g TRC101 BID	25
Overall Study	STARTED	3g TRC101 BID	25
Overall Study	STARTED	4.5g TRC101 BID	26
Overall Study	STARTED	Placebo QD	6
Overall Study	STARTED	6g TRC101 QD	28
Overall Study	COMPLETED	Placebo BID	25
Overall Study	COMPLETED	1.5g TRC101 BID	25
Overall Study	COMPLETED	3g TRC101 BID	25
Overall Study	COMPLETED	4.5g TRC101 BID	26

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Pooled Placebo	4	31
other	Diarrhoea	Gastrointestinal disorders	1.5g TRC101 BID	9	25
other	Diarrhoea	Gastrointestinal disorders	3g TRC101 BID	3	25
other	Diarrhoea	Gastrointestinal disorders	4.5g TRC101 BID	6	26
other	Diarrhoea	Gastrointestinal disorders	6g TRC101 QD	3	28
other	Constipation	Gastrointestinal disorders	Pooled Placebo	0	31
other	Constipation	Gastrointestinal disorders	1.5g TRC101 BID	1	25
other	Constipation	Gastrointestinal disorders	3g TRC101 BID	1	25
other	Constipation	Gastrointestinal disorders	4.5g TRC101 BID	2	26
other	Constipation	Gastrointestinal disorders	6g TRC101 QD	3	28

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pooled Placebo	0	31
Total, all-cause mortality	1.5g TRC101 BID	0	25
Total, all-cause mortality	3g TRC101 BID	0	25
Total, all-cause mortality	4.5g TRC101 BID	0	26
Total, all-cause mortality	6g TRC101 QD	0	28
Total, other adverse events	Pooled Placebo	12	31
Total, other adverse events	1.5g TRC101 BID	13	25
Total, other adverse events	3g TRC101 BID	9	25
Total, other adverse events	4.5g TRC101 BID	17	26
Total, other adverse events	6g TRC101 QD	13	28

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29102959	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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