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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003825-41 | EudraCT Number |
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This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily.
The maximum study duration is anticipated to be up to 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRC101 | Experimental | Administered once daily (QD) for 12 weeks |
|
| Placebo | Placebo Comparator | Administered once daily (QD) for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRC101 | Drug | Oral suspension |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range | 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). | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Treatment in Serum Bicarbonate | Mean change from baseline to end of treatment (Week 12 Visit) in serum bicarbonate | Baseline to Week 12 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Operations | Tricida, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site 55 | Phoenix | Arizona | 85032 | United States | ||
| Investigative Site 56 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30857647 | Result | Wesson DE, Mathur V, Tangri N, Stasiv Y, Parsell D, Li E, Klaerner G, Bushinsky DA. Veverimer versus placebo in patients with metabolic acidosis associated with chronic kidney disease: a multicentre, randomised, double-blind, controlled, phase 3 trial. Lancet. 2019 Apr 6;393(10179):1417-1427. doi: 10.1016/S0140-6736(18)32562-5. Epub 2019 Mar 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TRC101 Treatment Arm | The first dose of blinded study drug (2 packets for a total of 6 g TRC101) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, TRC101 was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 3 or 9 g (0, 1 or 3 packets, respectively) of TRC101 QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 27, 2017 | Mar 4, 2021 |
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| Placebo |
| Drug |
Oral suspension |
|
| Chula Vista |
| California |
| 91910 |
| United States |
| Investigative Site 91 | Los Angeles | California | 90022 | United States |
| Investigative Site 59 | Hialeah | Florida | 33015 | United States |
| Investigative Site 54 | Hollywood | Florida | 33021 | United States |
| Investigative Site 93 | Hollywood | Florida | 33024 | United States |
| Investigative Site 92 | Lauderdale Lakes | Florida | 33313 | United States |
| Investigative Site 51 | Tampa | Florida | 33614 | United States |
| Investigative Site 57 | Winter Park | Florida | 32789 | United States |
| Investigative Site 95 | Atlanta | Georgia | 30342 | United States |
| Investigative Site 53 | Shreveport | Louisiana | 71101 | United States |
| Investigative Site 58 | Flushing | New York | 11355 | United States |
| Investigative Site 52 | San Antonio | Texas | 78215 | United States |
| Investigative Site 11 | Sofia | Bulgaria |
| Investigative Site 21 | Zagreb | Croatia |
| Investigative Site 31 | Tbilisi | Georgia |
| Investigative Site 32 | Tbilisi | Georgia |
| Investigative Site 33 | Tbilisi | Georgia |
| Investigative Site 34 | Tbilisi | Georgia |
| Investigative Site 35 | Tbilisi | Georgia |
| Investigative Site 36 | Tbilisi | Georgia |
| Investigative Site 37 | Tbilisi | Georgia |
| Investigative Site 43 | Baja | Hungary |
| Investigative Site 48 | Balatonfüred | Hungary |
| Investigative Site 41 | Budapest | Hungary |
| Investigative Site 46 | Budapest | Hungary |
| Investigative Site 45 | Hatvan | Hungary |
| Investigative Site 49 | Hódmezővásárhely | Hungary |
| Investigative Site 44 | Kistarcsa | Hungary |
| Investigative Site 42 | Miskolc | Hungary |
| Investigative Site 47 | Mosonmagyaróvár | Hungary |
| Investigative Site 64 | Belgrade | Serbia |
| Investigative Site 65 | Belgrade | Serbia |
| Investigative Site 61 | Vršac | Serbia |
| Investigative Site 62 | Zrenjanin | Serbia |
| Investigative Site 72 | Jesenice | Slovenia |
| Investigative Site 71 | Maribor | Slovenia |
| Investigative Site 81 | Kharkiv | Ukraine |
| Investigative Site 83 | Kharkiv | Ukraine |
| Investigative Site 87 | Kharkiv | Ukraine |
| Investigative Site 88 | Kharkiv | Ukraine |
| Investigative Site 84 | Kyiv | Ukraine |
| Investigative Site 85 | Kyiv | Ukraine |
| Investigative Site 86 | Kyiv | Ukraine |
| FG001 | Placebo Treatment Arm | The first dose of blinded study drug (2 packets of placebo) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, placebo was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 1 or 3 packets of placebo QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TRC101 Treatment Arm | The first dose of blinded study drug (2 packets for a total of 6 g TRC101) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, TRC101 was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 3 or 9 g (0, 1 or 3 packets, respectively) of TRC101 QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E. |
| BG001 | Placebo Treatment Arm | The first dose of blinded study drug (2 packets of placebo) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, placebo was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 1 or 3 packets of placebo QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age (years) was calculated as the number of years between date of birth and date of informed consent, expressed as an integer. | Count of Participants | Participants |
| |||||||||||||||||
| Age, Continuous | Age (years) was calculated as the number of years between date of birth and date of informed consent, expressed as an integer. | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| History of Hypertension | Count of Participants | Participants |
| ||||||||||||||||||
| History of Diabetes Mellitus | Count of Participants | Participants |
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| History of Congestive Heart Failure | Count of Participants | Participants |
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| Baseline Estimated Glomerular Filtration Rate (eGFR) | Baseline eGFR was defined as the average of the values of eGFR collected at the Screening 1 Visit, Screening 2 Visit, and Baseline Visit (i.e., Day 1 pre-dose), based on serum creatinine values measured by the central laboratory and using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. | Mean | Standard Deviation | mL/min/1.73m^2 |
| ||||||||||||||||
| Baseline Bicarbonate | Baseline Bicarbonate was defined as the average of the values of serum bicarbonate collected at the Screening 1 Visit, Screening 2 Visit, and Baseline Visit (i.e., Day 1 pre-dose), measured onsite using an i-STAT point-of-care device. | Mean | Standard Deviation | mEq/L |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Week 12 |
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| Secondary | Change From Baseline to End of Treatment in Serum Bicarbonate | Mean change from baseline to end of treatment (Week 12 Visit) in serum bicarbonate | 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. | Posted | Least Squares Mean | 95% Confidence Interval | mEq/L | Baseline to Week 12 |
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Data are the number of patients with adverse events occurring on or after the date of the first dose of TRC101 or placebo up to 14 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TRC101 Treatment Arm | The first dose of blinded study drug (2 packets of TRC101 [6 g]) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, TRC101 was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 3 or 9 g (0, 1 or 3 packets, respectively) of TRC101 QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E. | 0 | 124 | 3 | 124 | 31 | 124 |
| EG001 | Placebo Treatment Arm | The first dose of blinded study drug (2 packets of placebo) was given at the study site on Day 1 in the morning with food. For the remainder of the Treatment Period, placebo was self-administered orally as an aqueous suspension, QD with lunch, for 12 weeks. Beginning at the Week 4 Visit, subjects could have had a blinded dose adjustment to 0, 1 or 3 packets of placebo QD in accordance with a protocol-specified titration algorithm. The last dose of study drug was to be taken the day before the Week 12 Visit, unless the subject was enrolled in the extension Study TRCA-301E. | 2 | 93 | 2 | 93 | 13 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Acute left ventricular failure | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Diabetic hyperglycaemic coma | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Tricida, Inc. | 415-429-7800 | medinfo@tricida.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2018 | Mar 4, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000138 | Acidosis |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000630913 | veverimer |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Subjects with serum bicarbonate in normal range |
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% Subjects with ≥ 4 mEq/L Change from Baseline in Serum Bicarbonate: TRC101-Placebo
| Fisher Exact |
| < 0.0001 |
| Treatment difference in % of subjects |
| 34.5 |
| 2-Sided |
| 95 |
| 21.2 |
| 46.8 |
| Superiority |
| % Subjects with Serum Bicarbonate in the Normal Range (22 - 29 mEq/L): TRC101-Placebo | Fisher Exact | < 0.0001 | Treatment difference in % of subjects | 33.1 | 2-Sided | 95 | 19.7 | 45.6 | Superiority |
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