Trial · NCT03317444
Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
NCT03317444, Phase 3, Completed, Tricida, Inc.; results first posted 2021-04-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease. Trials, record NCT03317444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03317444
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
- NCT number
- NCT03317444
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 217 participants, actual
- Lead sponsor
- Tricida, Inc.
- Conditions
- Metabolic Acidosis
- Interventions
- TRC101, Placebo
- First posted
- 2017-10-23
- Last updated
- 2021-04-26
- Other registries' IDs
- eudract:2016-003825-41
- Results first posted
- 2021-04-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range | Baseline to Week 12 | 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 | Change From Baseline to End of Treatment in Serum Bicarbonate | Baseline to Week 12 | Mean change from baseline to end of treatment (Week 12 Visit) in serum bicarbonate |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range | Baseline to Week 12 | The Modified Intent-to-Treat (MITT) Analysis Set was defined as all randomized subjects who had both baseline and at least one postbaseline serum bicarbonate value measured using an i-STAT device. The MITT Analysis Set was used for evaluation of efficacy, based on planned treatment assignment. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to End of Treatment in Serum Bicarbonate | Baseline to Week 12 | The Modified Intent-to-Treat (MITT) Analysis Set was defined as all randomized subjects who had both baseline and at least one postbaseline serum bicarbonate value measured using an i-STAT device. The MITT Analysis Set was used for evaluation of efficacy, based on planned treatment assignment. For this outcome measure, the analysis was done using a mixed model. | mEq/L | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range | TRC101 Treatment Arm | Subjects with change from baseline serum bicarbonate ≥ 4 mEq/L or serum bicarbonate in normal range | 59.2 | 95% Confidence Interval 49.8 to 68.0 | percentage of participants |
| Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range | Placebo Treatment Arm | Subjects with change from baseline serum bicarbonate ≥ 4 mEq/L or serum bicarbonate in normal range | 22.5 | 95% Confidence Interval 14.3 to 32.6 | percentage of participants |
| Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range | TRC101 Treatment Arm | Subjects with change from baseline serum bicarbonate ≥ 4 mEq/L | 55.8 | 95% Confidence Interval 46.5 to 64.9 | percentage of participants |
| Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range | Placebo Treatment Arm | Subjects with change from baseline serum bicarbonate ≥ 4 mEq/L | 21.3 | 95% Confidence Interval 13.4 to 31.3 | percentage of participants |
| Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range | TRC101 Treatment Arm | Subjects with serum bicarbonate in normal range | 50.0 | 95% Confidence Interval 40.7 to 59.3 | percentage of participants |
| Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range | Placebo Treatment Arm | Subjects with serum bicarbonate in normal range | 16.9 | 95% Confidence Interval 9.8 to 26.3 | percentage of participants |
| Change From Baseline to End of Treatment in Serum Bicarbonate | TRC101 Treatment Arm | 4.42 | 95% Confidence Interval 3.85 to 4.98 | mEq/L | |
| Change From Baseline to End of Treatment in Serum Bicarbonate | Placebo Treatment Arm | 1.78 | 95% Confidence Interval 1.13 to 2.44 | mEq/L |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TRC101 Treatment Arm | 124 | |
| Overall Study | STARTED | Placebo Treatment Arm | 93 | |
| Overall Study | COMPLETED | TRC101 Treatment Arm | 119 | |
| Overall Study | COMPLETED | Placebo Treatment Arm | 89 | |
| Overall Study | NOT COMPLETED | TRC101 Treatment Arm | 5 | |
| Overall Study | NOT COMPLETED | Placebo Treatment Arm | 4 |
Source ClinicalTrials.gov
Adverse events22
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 | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | TRC101 Treatment Arm | 7 | 124 | 7 |
| other | Headache | Nervous system disorders | Placebo Treatment Arm | 4 | 93 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | TRC101 Treatment Arm | 11 | 124 | 20 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Treatment Arm | 3 | 93 | 6 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | TRC101 Treatment Arm | 13 | 124 | 16 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Placebo Treatment Arm | 6 | 93 | 6 |
| serious | Fall | Injury, poisoning and procedural complications | TRC101 Treatment Arm | 1 | 124 | 1 |
| serious | Fall | Injury, poisoning and procedural complications | Placebo Treatment Arm | 0 | 93 | 0 |
| serious | Angina unstable | Cardiac disorders | TRC101 Treatment Arm | 0 | 124 | 0 |
| serious | Angina unstable | Cardiac disorders | Placebo Treatment Arm | 1 | 93 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TRC101 Treatment Arm | 0 | 124 |
| Total, all-cause mortality | Placebo Treatment Arm | 2 | 93 |
| Total, other adverse events | TRC101 Treatment Arm | 31 | 124 |
| Total, other adverse events | Placebo Treatment Arm | 13 | 93 |
| Total, serious adverse events | TRC101 Treatment Arm | 3 | 124 |
| Total, serious adverse events | Placebo Treatment Arm | 2 | 93 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30857647 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TRC101 Treatment Arm vs Placebo Treatment Arm: deaths from any cause | Trial comparisons |
| TRC101 Treatment Arm vs Placebo Treatment Arm: serious adverse events | Trial comparisons |
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03317444
GET https://conductscience.org/api/trials/v1/NCT03317444/events?page=2