Trial Outcomes & Findings for Long-term Safety Extension to Study TRCA-301 (NCT NCT03390842)

Last Updated: 2021-10-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

196 participants

Primary outcome timeframe

Week 12 Visit in the parent study, TRCA-301, to the Week 54 Visit in the extension study, TRCA-301E.

Results posted on

2021-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	TRC101 Treatment Arm TRC101 was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded TRC101 dose they were receiving in the parent study, TRCA-301, as follows: 0, 3, 6 or 9 g TRC101 QD (0, 1, 2 or 3 packets, respectively). Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.	Placebo Treatment Arm Placebo was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded placebo dose they were receiving in the parent study, TRCA-301, as follows: 0, 1, 2 or 3 placebo packets QD. Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
Overall Study STARTED	114	82
Overall Study COMPLETED	111	74
Overall Study NOT COMPLETED	3	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-term Safety Extension to Study TRCA-301

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TRC101 Treatment Arm n=114 Participants TRC101 was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded TRC101 dose they were receiving in the parent study, TRCA-301, as follows: 0, 3, 6 or 9 g TRC101 QD (0, 1, 2 or 3 packets, respectively). Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.	Placebo Treatment Arm n=82 Participants Placebo was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded placebo dose they were receiving in the parent study, TRCA-301, as follows: 0, 1, 2 or 3 placebo packets QD. Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.	Total n=196 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=5 Participants	44 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	58 Participants n=5 Participants	38 Participants n=7 Participants	96 Participants n=5 Participants
Age, Continuous	62.9 years STANDARD_DEVIATION 12.07 • n=5 Participants	61.7 years STANDARD_DEVIATION 11.88 • n=7 Participants	62.4 years STANDARD_DEVIATION 11.98 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	31 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	51 Participants n=7 Participants	119 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	113 Participants n=5 Participants	79 Participants n=7 Participants	192 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
History of Hypertension	110 Participants n=5 Participants	79 Participants n=7 Participants	189 Participants n=5 Participants
History of Diabetes Mellitus	70 Participants n=5 Participants	57 Participants n=7 Participants	127 Participants n=5 Participants
History of Congestive Heart Failure	34 Participants n=5 Participants	28 Participants n=7 Participants	62 Participants n=5 Participants
Baseline eGFR	29.4 mL/min/1.73m^2 STANDARD_DEVIATION 6.41 • n=5 Participants	27.9 mL/min/1.73m^2 STANDARD_DEVIATION 5.42 • n=7 Participants	28.8 mL/min/1.73m^2 STANDARD_DEVIATION 6.05 • n=5 Participants
Baseline Bicarbonate	17.21 mEq/L STANDARD_DEVIATION 1.429 • n=5 Participants	17.13 mEq/L STANDARD_DEVIATION 1.501 • n=7 Participants	17.17 mEq/L STANDARD_DEVIATION 1.457 • n=5 Participants

PRIMARY outcome

Timeframe: Week 12 Visit in the parent study, TRCA-301, to the Week 54 Visit in the extension study, TRCA-301E.

Population: The TRCA-301E Safety Analysis Set included all subjects who received any amount of study drug (TRC101 or placebo) in Study TRCA-301E.

Outcome measures

Outcome measures
Measure	TRC101 Treatment Arm n=112 Participants TRC101 was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded TRC101 dose they were receiving in the parent study, TRCA-301, as follows: 0, 3, 6 or 9 g TRC101 QD (0, 1, 2 or 3 packets, respectively). Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.	Placebo Treatment Arm n=81 Participants Placebo was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded placebo dose they were receiving in the parent study, TRCA-301, as follows: 0, 1, 2 or 3 placebo packets QD. Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal.	0 percentage of participants	1.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.

Population: 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.

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).

Outcome measures

Outcome measures
Measure	TRC101 Treatment Arm n=110 Participants TRC101 was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded TRC101 dose they were receiving in the parent study, TRCA-301, as follows: 0, 3, 6 or 9 g TRC101 QD (0, 1, 2 or 3 packets, respectively). Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.	Placebo Treatment Arm n=74 Participants Placebo was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded placebo dose they were receiving in the parent study, TRCA-301, as follows: 0, 1, 2 or 3 placebo packets QD. Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range	62.7 percentage of participants Interval 53.0 to 71.8	37.8 percentage of participants Interval 26.8 to 49.9

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	TRC101 Treatment Arm n=114 Participants TRC101 was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded TRC101 dose they were receiving in the parent study, TRCA-301, as follows: 0, 3, 6 or 9 g TRC101 QD (0, 1, 2 or 3 packets, respectively). Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.	Placebo Treatment Arm n=82 Participants Placebo was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded placebo dose they were receiving in the parent study, TRCA-301, as follows: 0, 1, 2 or 3 placebo packets QD. Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
Change From Baseline in Serum Bicarbonate at the End of Treatment	4.70 mEq/L Standard Error 0.335	2.71 mEq/L Standard Error 0.403

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TRC101 Treatment Arm n=113 Participants TRC101 was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded TRC101 dose they were receiving in the parent study, TRCA-301, as follows: 0, 3, 6 or 9 g TRC101 QD (0, 1, 2 or 3 packets, respectively). Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.	Placebo Treatment Arm n=78 Participants Placebo was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded placebo dose they were receiving in the parent study, TRCA-301, as follows: 0, 1, 2 or 3 placebo packets QD. Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment	11.42 KDQOL-PFD total score Standard Error 2.201	-0.71 KDQOL-PFD total score Standard Error 2.268

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TRC101 Treatment Arm n=112 Participants TRC101 was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded TRC101 dose they were receiving in the parent study, TRCA-301, as follows: 0, 3, 6 or 9 g TRC101 QD (0, 1, 2 or 3 packets, respectively). Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.	Placebo Treatment Arm n=77 Participants Placebo was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded placebo dose they were receiving in the parent study, TRCA-301, as follows: 0, 1, 2 or 3 placebo packets QD. Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment	-4.28 seconds Standard Error 1.240	-1.42 seconds Standard Error 1.248

Adverse Events

TRC101 Treatment Arm

Serious events: 2 serious events

Other events: 78 other events

Deaths: 0 deaths

Placebo Treatment Arm

Serious events: 4 serious events

Other events: 39 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	TRC101 Treatment Arm n=112 participants at risk TRC101 was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded TRC101 dose they were receiving in the parent study, TRCA-301, as follows: 0, 3, 6 or 9 g TRC101 QD (0, 1, 2 or 3 packets, respectively). Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.	Placebo Treatment Arm n=81 participants at risk Placebo was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded placebo dose they were receiving in the parent study, TRCA-301, as follows: 0, 1, 2 or 3 placebo packets QD. Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
Cardiac disorders Cardiac failure congestive	0.00% 0/112 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	1.2% 1/81 • Number of events 1 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Cardiac disorders Angina unstable	0.89% 1/112 • Number of events 1 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	0.00% 0/81 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Cardiac disorders Cardiac failure	0.89% 1/112 • Number of events 1 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	0.00% 0/81 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Nervous system disorders Cerebrovascular accident	0.00% 0/112 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	1.2% 1/81 • Number of events 1 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Gastrointestinal disorders Abdominal discomfort	0.89% 1/112 • Number of events 1 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	0.00% 0/81 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Renal and urinary disorders Renal impairment	0.00% 0/112 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	1.2% 1/81 • Number of events 1 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Renal and urinary disorders Azotaemia	0.00% 0/112 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	1.2% 1/81 • Number of events 1 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Renal and urinary disorders Chronic kidney disease	0.89% 1/112 • Number of events 1 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	0.00% 0/81 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/112 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	1.2% 1/81 • Number of events 1 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/112 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	1.2% 1/81 • Number of events 1 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Infections and infestations Pneumonia	0.00% 0/112 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	1.2% 1/81 • Number of events 1 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.

Other adverse events

Other adverse events
Measure	TRC101 Treatment Arm n=112 participants at risk TRC101 was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded TRC101 dose they were receiving in the parent study, TRCA-301, as follows: 0, 3, 6 or 9 g TRC101 QD (0, 1, 2 or 3 packets, respectively). Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.	Placebo Treatment Arm n=81 participants at risk Placebo was self-administered orally as an aqueous suspension, QD with food, at approximately the same time each day for 40 weeks. Subjects entered the study on the same blinded placebo dose they were receiving in the parent study, TRCA-301, as follows: 0, 1, 2 or 3 placebo packets QD. Subjects could have had a blinded dose adjustment using these same doses in accordance with a protocol-specified titration algorithm at each study visit.
Blood and lymphatic system disorders Anaemia	5.4% 6/112 • Number of events 6 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	1.2% 1/81 • Number of events 1 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 7/112 • Number of events 7 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	3.7% 3/81 • Number of events 3 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Nervous system disorders Headache	15.2% 17/112 • Number of events 19 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	24.7% 20/81 • Number of events 22 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Gastrointestinal disorders Flatulence	7.1% 8/112 • Number of events 8 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	6.2% 5/81 • Number of events 5 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Gastrointestinal disorders Diarrhoea	6.2% 7/112 • Number of events 8 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	6.2% 5/81 • Number of events 5 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Renal and urinary disorders Renal impairment	4.5% 5/112 • Number of events 5 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	8.6% 7/81 • Number of events 7 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Metabolism and nutrition disorders Hyperkalaemia	14.3% 16/112 • Number of events 19 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	9.9% 8/81 • Number of events 9 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.
Infections and infestations Influenza	10.7% 12/112 • Number of events 13 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.	7.4% 6/81 • Number of events 6 • Week 12 visit in the parent study, TRCA-301, to the Week 54 follow-up 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 TRCA-301E. Three subjects were excluded (2 TRC101, 1 placebo) because they entered TRCA-301E on a dose hold and remained on the dose hold for the duration of the study because their bicarbonate levels remained within the normal range.

Additional Information

Medical Information

Tricida, Inc.

Phone: 415-429-7800

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