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    Clinical Trial Results:
    A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TRC101 in Subjects with Chronic Kidney Disease and Metabolic Acidosis

    Summary
    EudraCT number
    		 2016-003825-41
    Trial protocol
    		 HU   BG   SI   HR  
    Global end of trial date
    15 May 2018

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Sep 2021
    First version publication date
    10 Jul 2020
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of demographic data for subjects < 65 years old and subjects => 65 years old. Correction of number of subjects in each treatment arm for the secondary endpoint (change from baseline to end of treatment in serum bicarbonate).

    Trial information

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    Trial identification
    Sponsor protocol code
    TRCA-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03317444
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Tricida, Inc.
    Sponsor organisation address
    7000 Shoreline Ct, Suite 201, South San Francisco, CA, United States, 94080
    Public contact
    Clinical Operations, Tricida, Inc., 01 4159885120, ystasiv@tricida.com
    Scientific contact
    Clinical Operations, Tricida, Inc., 01 4159885120, ystasiv@tricida.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Apr 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of TRC101 in chronic kidney disease (CKD) patients with metabolic acidosis (serum bicarbonate 12 – 20 mEq/L). The secondary objective of the study was to evaluate the safety of administration of TRC101 in CKD patients with metabolic acidosis (serum bicarbonate 12 – 20 mEq/L).
    Protection of trial subjects
    The design and conduct of TRCA-301 included appropriate monitoring for safety and risk mitigation. The Medical Monitor reviewed blinded safety data on an ongoing basis to identify potential adverse safety trends. Central laboratory reports contained flags that alerted investigators and Tricida personnel to abnormal, critical, and exclusionary laboratory values, and the Medical Monitor routinely reviewed these results as well as adverse events on an ongoing basis. Electrolytes and serum bicarbonate levels were monitored at every study visit. An Independent Data Monitoring Committee reviewed unblinded safety data during the study on a regular basis. All Investigators participating in this study were governed under an appropriate Institutional Review Board (IRB)/Independent Ethics Committee (IEC). The protocol, informed consent form (ICF) and any information provided to subjects was approved by the responsible IRB/IEC before enrollment of participants in the study at each investigational site. The Investigator was responsible for informing the IRBs/IECs of any reportable serious adverse events (SAEs) or other significant safety concerns, as well as the progress of the study, including completion or termination. This study was conducted in accordance with United States (US) Food and Drug Administration (FDA) regulations, the International Council on Harmonisation (ICH) guideline E6 (R2), Guideline for Good Clinical Practice (9 November 2016), the Declaration of Helsinki, and IRB/IEC requirements. The study was also conducted in accordance with the European Union Clinical Trials Directive 2001/20/EC (EU CTD) for sites in the EU and all other applicable local and national laws and regulations governing the conduct of human clinical trials.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Sep 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 9 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovenia: 3
    Country: Number of subjects enrolled
    Croatia: 1
    Country: Number of subjects enrolled
    Bulgaria: 68
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Serbia: 3
    Country: Number of subjects enrolled
    Ukraine: 25
    Country: Number of subjects enrolled
    United States: 27
    Country: Number of subjects enrolled
    Georgia: 80
    Worldwide total number of subjects
    217
    EEA total number of subjects
    82
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    103
    From 65 to 84 years
    113
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 After potential subjects provided informed consent, their eligibility was to be evaluated based on laboratory values, medical history, concomitant medications, vital signs, pregnancy test (if applicable) and physical examination. Subjects were 18 – 85 years of age with CKD (eGFR of 20 – 40 mL/min/1.73m^2) and low serum bicarbonate (12 – 20 mEq/L).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TRC101 Treatment Arm
    Arm description
    		 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 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    veverimer
    Investigational medicinal product code
    Other name
    TRC101
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TRC101 was orally administered QD as a 3, 6 or 9 g dose (1, 2 or 3 packets, respectively) suspended in approximately 60 – 90 mL of water.

    Arm title
    		 Placebo Treatment Arm
    Arm description
    		 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 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.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was supplied as a powder for oral suspension in packets. Placebo (1, 2, or 3 packets) was orally administered QD as a suspension in approximately 60 – 90 mL of water.

    Number of subjects in period 1
    		TRC101 Treatment Arm Placebo Treatment Arm
    Started
    124
    93
    Completed
    119
    89
    Not completed
    5
    4
         Adverse event, serious fatal
    -
    2
         Consent withdrawn by subject
    2
    1
         Need for dialysis
    1
    -
         Adverse event, non-fatal
    1
    1
         Subject unable to attend visits due to rehab
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TRC101 Treatment Arm
    Reporting group description
    		 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 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.

    Reporting group title
    Placebo Treatment Arm
    Reporting group description
    		 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 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.

    Reporting group values
    		 TRC101 Treatment Arm Placebo Treatment Arm Total
    Number of subjects
    		 124 93 217
    Age categorical
    Age (years) was calculated as the number of years between date of birth and date of informed consent, expressed as an integer.
    Units: Subjects
        < 65 years
    		 59 44 103
        ≥ 65 years
    		 65 49 114
    Age continuous
    Age (years) was calculated as the number of years between date of birth and date of informed consent, expressed as an integer.
    Units: years
        arithmetic mean (standard deviation)
    		 62.9 ( 12.64 ) 63.3 ( 12.08 ) -
    Gender categorical
    Units: Subjects
        Female
    		 50 33 83
        Male
    		 74 60 134
    History of Hypertension
    Units: Subjects
        Yes
    		 120 90 210
        No
    		 4 3 7
    History of Diabetes Mellitus
    Units: Subjects
        Yes
    		 76 65 141
        No
    		 48 28 76
    History of Congestive Heart Failure
    Units: Subjects
        Yes
    		 36 31 67
        No
    		 88 62 150
    Baseline 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 CKD-EPI formula.
    Units: mL/min/1.73m^2
        arithmetic mean (standard deviation)
    		 29.2 ( 6.29 ) 27.8 ( 5.45 ) -
    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.
    Units: mEq/L
        arithmetic mean (standard deviation)
    		 17.27 ( 1.429 ) 17.30 ( 1.504 ) -

    End points

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    End points reporting groups
    Reporting group title
    TRC101 Treatment Arm
    Reporting group description
    		 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 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.

    Reporting group title
    Placebo Treatment Arm
    Reporting group description
    		 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 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.

    Primary: Subjects with change from baseline in serum bicarbonate of ≥ 4 mEq/L or serum bicarbonate within the normal range

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    End point title
    		 Subjects with change from baseline in serum bicarbonate of ≥ 4 mEq/L or serum bicarbonate within the normal range
    End point description
    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).
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 TRC101 Treatment Arm Placebo Treatment Arm
    Number of subjects analysed
    120
    89
    Units: percent
        number (confidence interval 95%)
    59.2 (49.8 to 68.0)
    22.5 (14.3 to 32.6)
    Attachments
    		 Untitled (Filename: TRCA-301_Primary Endpoint Chart.pdf)
    Statistical analysis title
    		 % Subjects Who Met Endpoint: TRC101-Placebo
    Comparison groups
    TRC101 Treatment Arm v Placebo Treatment Arm
    Number of subjects included in analysis
    209
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Parameter type
    		 Treatment difference in % of subjects
    Point estimate
    36.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 23.5
         upper limit
    		 48.9
    Statistical analysis title
    		 % Subjects ≥4mEq/L Change from Baseline:TRC101-PBO
    Comparison groups
    TRC101 Treatment Arm v Placebo Treatment Arm
    Number of subjects included in analysis
    209
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Parameter type
    		 Treatment difference in % of subjects
    Point estimate
    34.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.2
         upper limit
    		 46.8
    Statistical analysis title
    		 % Subjects within Normal Range: TRC101-PBO
    Comparison groups
    TRC101 Treatment Arm v Placebo Treatment Arm
    Number of subjects included in analysis
    209
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Parameter type
    		 Treatment difference in % of subjects
    Point estimate
    33.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.7
         upper limit
    		 45.6

    Secondary: Change from baseline to end of treatment in serum bicarbonate

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    End point title
    		 Change from baseline to end of treatment in serum bicarbonate
    End point description
    Mean change from baseline to end of treatment (Week 12 Visit) in serum bicarbonate
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 TRC101 Treatment Arm Placebo Treatment Arm
    Number of subjects analysed
    123
    93
    Units: mEq/L
        least squares mean (confidence interval 95%)
    4.42 (3.85 to 4.98)
    1.78 (1.13 to 2.44)
    Attachments
    		 Untitled (Filename: TRCA-301_Secondary Endpoint Chart.pdf)
    Statistical analysis title
    		 Mean Change from Baseline: TRC101-Placebo
    Comparison groups
    TRC101 Treatment Arm v Placebo Treatment Arm
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed-effect repeated measures model
    Parameter type
    		 Treatment difference in LS means
    Point estimate
    2.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.77
         upper limit
    		 3.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.44

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Data are the number of patients with adverse events occurring on or after the date of the first dose of TRC101 or placebo.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Active Treatment Arm
    Reporting group description
    		 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 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.

    Reporting group title
    Placebo Treatment Arm
    Reporting group description
    		 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 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.

    Serious adverse events
    		 Active Treatment Arm Placebo Treatment Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 124 (2.42%)
    2 / 93 (2.15%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    2
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute left ventricular failure
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Diabetic hyperglycaemic coma
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Active Treatment Arm Placebo Treatment Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 124 (25.00%)
    13 / 93 (13.98%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 124 (5.65%)
    4 / 93 (4.30%)
         occurrences all number
    7
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    11 / 124 (8.87%)
    3 / 93 (3.23%)
         occurrences all number
    20
    6
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    13 / 124 (10.48%)
    6 / 93 (6.45%)
         occurrences all number
    16
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jun 2017
    Original Protocol. Note: No subjects were enrolled under the original protocol.
    31 Jul 2017
    Protocol Amendment 1: The primary endpoint was revised to be based on a responder analysis, in order to assess the magnitude of the treatment effect of TRC101 on blood bicarbonate, for the purpose of powering future investigational studies of TRC101. The restrictions on management of common underlying comorbidities with concomitant medications were relaxed, while minimizing potential impact on blood bicarbonate by changes in concomitant medications, to align the management of concomitant medications with future investigational studies of TRC101. The inclusion and exclusion criteria were revised to ensure that study population reflects the population to be enrolled in future investigational studies of TRC101. Note: No subjects were enrolled under protocol amendment 1.
    01 Sep 2017
    Protocol Amendment 2: The design of the extension study, TRCA-301E, conducted under a separate study protocol but mentioned in the parent study (TRCA-301), was changed from an open-label study to a blinded, placebo-controlled study, therefore references to the extension study in the TRCA-301 protocol as an open-label study required revision. In addition, revisions were made to the description of the efficacy endpoint analyses for consistency with the Statistical Analysis Plan and for clarification.
    15 Jan 2018
    Protocol Amendment 3: The upper limit of age eligibility was increased from 80 to 85 years in the inclusion criterion #2. This change was made to better reflect the age range of the TRC101 target population; enrollment of subjects between the ages of 80 and 85 years is consistent with other recent studies in the CKD stage 3/4 patient population.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30857647
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