Acidosis
Conditions
Keywords
metabolic acidosis, serum bicarbonate, kidney disease
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.
Interventions
DRUGPlacebo
oral suspension
DRUGTRC101
oral suspension
Sponsors
Tricida, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Bulgaria, Georgia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pooled Placebo Pooled placebo treatment groups (Placebo administered twice daily \[BID\] for 14 days + Placebo administered once daily \[QD\] for 14 days) | 31 |
| 1.5g TRC101 BID 1.5g TRC101 administered twice daily (BID) for 14 days | 25 |
| 3g TRC101 BID 3g TRC101 administered twice daily (BID) for 14 days | 25 |
| 4.5g TRC101 BID 4.5g TRC101 administered twice daily (BID) for 14 days | 26 |
| 6g TRC101 QD 6g TRC101 administered once daily (QD) for 14 days | 28 |
| Total | 135 |
Baseline characteristics
| Characteristic | Total | 1.5g TRC101 BID | 3g TRC101 BID | 4.5g TRC101 BID | Pooled Placebo | 6g TRC101 QD |
|---|---|---|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 12.44 | 58 years STANDARD_DEVIATION 14 | 60 years STANDARD_DEVIATION 13 | 61 years STANDARD_DEVIATION 13 | 61 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 11 |
| Diabetes | 94 Participants | 18 Participants | 20 Participants | 19 Participants | 20 Participants | 17 Participants |
| eGFR | 35.70 mL/min/1.73m^2 STANDARD_DEVIATION 12.419 | 35 mL/min/1.73m^2 STANDARD_DEVIATION 13 | 40 mL/min/1.73m^2 STANDARD_DEVIATION 13 | 35 mL/min/1.73m^2 STANDARD_DEVIATION 13 | 34 mL/min/1.73m^2 STANDARD_DEVIATION 14 | 31 mL/min/1.73m^2 STANDARD_DEVIATION 10 |
| Heart Failure | 29 Participants | 5 Participants | 7 Participants | 5 Participants | 7 Participants | 5 Participants |
| Hypertension | 126 Participants | 24 Participants | 23 Participants | 23 Participants | 30 Participants | 26 Participants |
| Serum Bicarbonate | 17.72 mEq/L STANDARD_DEVIATION 1.197 | 18.0 mEq/L STANDARD_DEVIATION 1 | 17.8 mEq/L STANDARD_DEVIATION 1.2 | 17.5 mEq/L STANDARD_DEVIATION 1.3 | 17.6 mEq/L STANDARD_DEVIATION 1.4 | 17.7 mEq/L STANDARD_DEVIATION 1 |
| Sex: Female, Male Female | 49 Participants | 6 Participants | 8 Participants | 11 Participants | 12 Participants | 12 Participants |
| Sex: Female, Male Male | 86 Participants | 19 Participants | 17 Participants | 15 Participants | 19 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 25 | 0 / 25 | 0 / 26 | 0 / 28 |
| other Total, other adverse events | 12 / 31 | 13 / 25 | 9 / 25 | 17 / 26 | 13 / 28 |
| serious Total, serious adverse events | 0 / 31 | 0 / 25 | 0 / 25 | 0 / 26 | 0 / 28 |
Outcome results
Primary
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
Time frame: Baseline and Day 15
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group | -0.2 mEq/L | Standard Error 0.4 |
| 1.5g TRC101 BID | Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group | 3.2 mEq/L | Standard Error 0.4 |
| 3g TRC101 BID | Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group | 3.0 mEq/L | Standard Error 0.4 |
| 4.5g TRC101 BID | Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group | 3.7 mEq/L | Standard Error 0.4 |
p-value: 0.554795% CI: [-0.9, 0.5]Mixed Models Analysis
Comparison: The null hypothesis is that the mean change from baseline within the 1.5g TRC101 BID treatment group = 0 mEq/L.p-value: <0.000195% CI: [2.4, 4]Mixed Models Analysis
p-value: <0.000195% CI: [2.2, 3.8]Mixed Models Analysis
p-value: <0.000195% CI: [2.9, 4.5]Mixed Models Analysis
Primary
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.
Time frame: Through treatment period completion (Day 15)
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | Subjects Reporting any TEAE | 14 Participants |
| Pooled Placebo | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Moderate TEAE | 3 Participants |
| Pooled Placebo | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | Study Drug Discontinuation Due to TEAE | 0 Participants |
| Pooled Placebo | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Serious TEAE | 0 Participants |
| Pooled Placebo | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Severe TEAE | 0 Participants |
| Pooled Placebo | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Mild TEAE | 11 Participants |
| 1.5g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | Subjects Reporting any TEAE | 13 Participants |
| 1.5g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Mild TEAE | 9 Participants |
| 1.5g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Moderate TEAE | 4 Participants |
| 1.5g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Severe TEAE | 0 Participants |
| 1.5g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Serious TEAE | 0 Participants |
| 1.5g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | Study Drug Discontinuation Due to TEAE | 0 Participants |
| 3g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Mild TEAE | 8 Participants |
| 3g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Serious TEAE | 0 Participants |
| 3g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | Subjects Reporting any TEAE | 9 Participants |
| 3g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Moderate TEAE | 1 Participants |
| 3g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | Study Drug Discontinuation Due to TEAE | 0 Participants |
| 3g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Severe TEAE | 0 Participants |
| 4.5g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | Study Drug Discontinuation Due to TEAE | 0 Participants |
| 4.5g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Moderate TEAE | 3 Participants |
| 4.5g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Severe TEAE | 0 Participants |
| 4.5g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | Subjects Reporting any TEAE | 17 Participants |
| 4.5g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Serious TEAE | 0 Participants |
| 4.5g TRC101 BID | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Mild TEAE | 14 Participants |
| 6g TRC101 QD | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Serious TEAE | 0 Participants |
| 6g TRC101 QD | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | Subjects Reporting any TEAE | 17 Participants |
| 6g TRC101 QD | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | Study Drug Discontinuation Due to TEAE | 0 Participants |
| 6g TRC101 QD | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Mild TEAE | 15 Participants |
| 6g TRC101 QD | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Severe TEAE | 0 Participants |
| 6g TRC101 QD | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE | ≥ 1 Moderate TEAE | 2 Participants |
Secondary
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
Time frame: Baseline and Day 15
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus Placebo | -0.2 mEq/L | Standard Error 0.4 |
| 1.5g TRC101 BID | Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus Placebo | 3.5 mEq/L | Standard Error 0.4 |
p-value: <0.000195% CI: [2.6, 4.7]Mixed Models Analysis
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
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
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pooled 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 | 3.0 mEq/L | Standard Error 0.4 |
| 1.5g TRC101 BID | Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus the TRC101 3g BID Dose Group | 3.5 mEq/L | Standard Error 0.4 |
p-value: 0.421495% CI: [-1.6, 0.7]Mixed Models Analysis
Secondary
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
Time frame: Baseline and Day 15
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Change From Baseline in Serum Bicarbonate at Day 15 Within the Combined TRC101 Treatment Group | 3.3 mEq/L | Standard Error 0.2 |
p-value: <0.000195% CI: [3, 3.7]Mixed Models Analysis
Secondary
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
Time frame: Baseline and Day 15
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Change From Baseline in Serum Bicarbonate at Day 15 Within the TRC101 6g QD Dose Group | 3.5 mEq/L | Standard Error 0.4 |
p-value: <0.000195% CI: [2.7, 4.2]Mixed Models Analysis
Secondary
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
Time frame: Baseline and Day 15
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo | -0.2 mEq/L | Standard Error 0.4 |
| 1.5g TRC101 BID | Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo | 3.2 mEq/L | Standard Error 0.4 |
| 3g TRC101 BID | Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo | 3.0 mEq/L | Standard Error 0.4 |
| 4.5g TRC101 BID | Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo | 3.7 mEq/L | Standard Error 0.4 |
p-value: <0.000195% CI: [2.3, 4.5]Mixed Models Analysis
p-value: <0.000195% CI: [2.2, 4.3]Mixed Models Analysis
p-value: <0.000195% CI: [2.9, 5]Mixed Models Analysis
Secondary
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
Time frame: Baseline and Day 15
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo | Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between the Combined TRC101 Treatment Group Versus Placebo | -0.2 mEq/L | Standard Error 0.4 |
| 1.5g TRC101 BID | Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between the Combined TRC101 Treatment Group Versus Placebo | 3.3 mEq/L | Standard Error 0.2 |
p-value: <0.000195% CI: [2.8, 4.4]Mixed Models Analysis
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
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
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo | 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 | => 2 mEq/L Baseline Serum Bicarbonate | 4 Participants |
| Pooled Placebo | 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 | => 3 mEq/L Baseline Serum Bicarbonate | 2 Participants |
| Pooled Placebo | 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 | => 4 mEq/L Baseline Serum Bicarbonate | 1 Participants |
| 1.5g TRC101 BID | 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 | => 2 mEq/L Baseline Serum Bicarbonate | 23 Participants |
| 1.5g TRC101 BID | 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 | => 3 mEq/L Baseline Serum Bicarbonate | 14 Participants |
| 1.5g TRC101 BID | 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 | => 4 mEq/L Baseline Serum Bicarbonate | 12 Participants |
p-value: <0.0001Fisher Exact
p-value: 0.0003Fisher Exact
p-value: 0.0003Fisher Exact
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
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
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled 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 | => 2 mEq/L Baseline Serum Bicarbonate | 4 Participants |
| Pooled 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 | => 4 mEq/L Baseline Serum Bicarbonate | 1 Participants |
| Pooled 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 | => 3 mEq/L Baseline Serum Bicarbonate | 2 Participants |
| 1.5g TRC101 BID | 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 | => 2 mEq/L Baseline Serum Bicarbonate | 18 Participants |
| 1.5g TRC101 BID | 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 | => 4 mEq/L Baseline Serum Bicarbonate | 8 Participants |
| 1.5g TRC101 BID | 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 | => 3 mEq/L Baseline Serum Bicarbonate | 14 Participants |
| 3g TRC101 BID | 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 | => 3 mEq/L Baseline Serum Bicarbonate | 10 Participants |
| 3g TRC101 BID | 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 | => 2 mEq/L Baseline Serum Bicarbonate | 14 Participants |
| 3g TRC101 BID | 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 | => 4 mEq/L Baseline Serum Bicarbonate | 10 Participants |
| 4.5g TRC101 BID | 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 | => 2 mEq/L Baseline Serum Bicarbonate | 19 Participants |
| 4.5g TRC101 BID | 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 | => 4 mEq/L Baseline Serum Bicarbonate | 11 Participants |
| 4.5g TRC101 BID | 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 | => 3 mEq/L Baseline Serum Bicarbonate | 16 Participants |
p-value: 0.0013Fisher Exact
p-value: <0.0001Fisher Exact
p-value: <0.0001Fisher Exact
p-value: 0.0074Fisher Exact
p-value: 0.0012Fisher Exact
p-value: 0.0032Fisher Exact
p-value: <0.0001Fisher Exact
p-value: <0.0001Fisher Exact
p-value: <0.0006Fisher Exact