Trial · NCT03390842
Long-term Safety Extension to Study TRCA-301
NCT03390842, Phase 3, Completed, Tricida, Inc.; results first posted 2021-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Safety Extension to Study TRCA-301. Trials, record NCT03390842. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03390842
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety Extension to Study TRCA-301
- NCT number
- NCT03390842
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 196 participants, actual
- Lead sponsor
- Tricida, Inc.
- Conditions
- Metabolic Acidosis
- Interventions
- TRC101, Placebo
- First posted
- 2018-01-04
- Last updated
- 2021-10-22
- Results first posted
- 2021-10-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal. | Week 12 Visit in the parent study, TRCA-301, to the Week 54 Visit in the extension study, TRCA-301E. | 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 | Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range | Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E. | 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). |
| Secondary | Change From Baseline in Serum Bicarbonate at the End of Treatment | Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E. | Change from baseline in serum bicarbonate at the end of treatment (Week 52). |
| Secondary | Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment | Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E. | 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. |
| Secondary | Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment | Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E. | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal. | Week 12 Visit in the parent study, TRCA-301, to the Week 54 Visit in the extension study, TRCA-301E. | The TRCA-301E Safety Analysis Set included all subjects who received any amount of study drug (TRC101 or placebo) in Study TRCA-301E. | percentage of participants | NUMBER |
| SECONDARY | Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range | Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E. | The TRCA-301E Modified Intent-to-Treat (MITT) Analysis Set included all randomized subjects who had both baseline and at least one postbaseline serum bicarbonate value measured using the i-STAT device in the parent study, TRCA-301, and at least one serum bicarbonate value after the Week 12 Visit in Study TRCA-301E. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Serum Bicarbonate at the End of Treatment | Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E. | The TRCA-301E Modified Intent-to-Treat (MITT) Analysis Set included all randomized subjects who had both baseline and at least one postbaseline serum bicarbonate value measured using the i-STAT device in the parent study, TRCA-301, and at least one serum bicarbonate value after the Week 12 Visit in Study TRCA-301E. | mEq/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment | Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E. | The TRCA-301E Modified Intent-to-Treat (MITT) Analysis Set included all randomized subjects who had both baseline and at least one postbaseline serum bicarbonate value measured using the i-STAT device in the parent study, TRCA-301, and at least one serum bicarbonate value after the Week 12 Visit in Study TRCA-301E. | KDQOL-PFD total score | MEAN |
| SECONDARY | Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment | Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E. | The TRCA-301E Modified Intent-to-Treat (MITT) Analysis Set included all randomized subjects who had both baseline and at least one postbaseline serum bicarbonate value measured using the i-STAT device in the parent study, TRCA-301, and at least one serum bicarbonate value after the Week 12 Visit in Study TRCA-301E. | seconds | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal. | TRC101 Treatment Arm | 0 | percentage of participants | ||
| Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal. | Placebo Treatment Arm | 1.2 | 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 | 62.7 | 95% Confidence Interval 53.0 to 71.8 | 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 | 37.8 | 95% Confidence Interval 26.8 to 49.9 | percentage of participants | |
| Change From Baseline in Serum Bicarbonate at the End of Treatment | TRC101 Treatment Arm | 4.70 | Standard Error 0.335 | mEq/L | |
| Change From Baseline in Serum Bicarbonate at the End of Treatment | Placebo Treatment Arm | 2.71 | Standard Error 0.403 | mEq/L | |
| Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment | TRC101 Treatment Arm | 11.42 | Standard Error 2.201 | KDQOL-PFD total score | |
| Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment | Placebo Treatment Arm | -0.71 | Standard Error 2.268 | KDQOL-PFD total score | |
| Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment | TRC101 Treatment Arm | -4.28 | Standard Error 1.240 | seconds | |
| Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment | Placebo Treatment Arm | -1.42 | Standard Error 1.248 | seconds |
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 | 114 | |
| Overall Study | STARTED | Placebo Treatment Arm | 82 | |
| Overall Study | COMPLETED | TRC101 Treatment Arm | 111 | |
| Overall Study | COMPLETED | Placebo Treatment Arm | 74 | |
| Overall Study | NOT COMPLETED | TRC101 Treatment Arm | 3 | |
| Overall Study | NOT COMPLETED | Placebo Treatment Arm | 8 |
Source ClinicalTrials.gov
Adverse events38
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 | Anaemia | Blood and lymphatic system disorders | TRC101 Treatment Arm | 6 | 112 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Treatment Arm | 1 | 81 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | TRC101 Treatment Arm | 7 | 112 | 7 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo Treatment Arm | 3 | 81 | 3 |
| other | Headache | Nervous system disorders | TRC101 Treatment Arm | 17 | 112 | 19 |
| other | Headache | Nervous system disorders | Placebo Treatment Arm | 20 | 81 | 22 |
| other | Flatulence | Gastrointestinal disorders | TRC101 Treatment Arm | 8 | 112 | 8 |
| other | Flatulence | Gastrointestinal disorders | Placebo Treatment Arm | 5 | 81 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | TRC101 Treatment Arm | 7 | 112 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Treatment Arm | 5 | 81 | 5 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 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 | 112 |
| Total, all-cause mortality | Placebo Treatment Arm | 2 | 81 |
| Total, other adverse events | TRC101 Treatment Arm | 78 | 112 |
| Total, other adverse events | Placebo Treatment Arm | 39 | 81 |
| Total, serious adverse events | TRC101 Treatment Arm | 2 | 112 |
| Total, serious adverse events | Placebo Treatment Arm | 4 | 81 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT03390842
GET https://conductscience.org/api/trials/v1/NCT03390842/events?page=2