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    Summary
    EudraCT Number:2016-003825-41
    Sponsor's Protocol Code Number:TRCA-301
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCroatia - MIZ
    A.2EudraCT number2016-003825-41
    A.3Full title of the trial
    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
    Multicentrično, randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze III za procjenu djelotvornosti i sigurnosti TRC101 u ispitanika s kroničnom bubrežnom bolesti i metaboličkom acidozom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of TRC101 in subjects with chronic kidney disease and metabolic acidosis
    A.4.1Sponsor's protocol code numberTRCA-301
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTricida, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTricida, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTricida, Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address7000 Shoreline Court, Suite 201
    B.5.3.2Town/ citySouth San Francisco, CA
    B.5.3.3Post code94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number014159885120
    B.5.6E-mailystasiv@tricida.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTRC101
    D.3.2Product code TRC101
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 2099678-27-8
    D.3.9.2Current sponsor codeTRC101
    D.3.9.3Other descriptive nameTRC101
    D.3.9.4EV Substance CodeSUB181567
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number9
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typePolymer
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for oral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metabolic acidosis associated with Chronic Kidney Disease
    E.1.1.1Medical condition in easily understood language
    Low blood bicarbonate levels in patients with chronic kidney disease
    (CKD)
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027417
    E.1.2Term Metabolic acidosis
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety of administration of TRC101 in CKD patients with
    metabolic acidosis (blood bicarbonate 12 to 20 mEq/L)
    To evaluate the efficacy of TRC101 in CKD patients with metabolic
    acidosis (blood bicarbonate 12 to 20 mEq/L)

    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Have provided written informed consent prior to participation in the study.
    2.Male or female subjects 18 to 85 years of age at the Screening 1 Visit.
    3.Have a blood bicarbonate value of 12 to 20 mEq/L at Screening 1 and Screening 2 Visits AND an average value for Screening 1, Screening 2, and Baseline Visits (i.e., baseline blood bicarbonate) within the range 12 to 20 mEq/L based on onsite measurement using an i-STAT point of care device.
    Screening 1 and Screening 2 Visits must be at least 5 days apart.
    Note: Subjects with baseline blood bicarbonate values of 12 to 18 mEq/L are eligible without restriction. Once 105 subjects with baseline blood bicarbonate values of > 18 to 20 mEq/L have been enrolled, randomization may be closed to additional subjects with baseline blood bicarbonate in this range.
    4.At both Screening Visits have an eGFR value of 20 to 40 mL/min/1.73m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation as reported by the central laboratory. If a central laboratory eGFR value at Screening 2 Visit is not available, eGFR can be calculated using CKD EPI equation based on onsite serum creatinine measurement at the Baseline Visit to establish subject’s eligibility.
    Screening 1 and Screening 2 Visits must be at least 5 days apart.
    5.Have stable renal function as defined by eGFR values at both Screening Visits that are not different by more than 20% (the higher of the two Screening eGFR values will be used as the denominator to calculate the 20% allowable difference).
    6.At both Screening Visits have systolic blood pressure < 170 mmHg (all three replicates).
    7.Have a hemoglobin A1c (HbA1c) value of ≤ 9.0% at the Screening 1 Visit based on central laboratory measurement.
    8.Have adequate peripheral venous access for blood draws.
    9.Women who are of childbearing potential must have negative pregnancy tests at the Screening 1 Visit and Day 1 and be willing to use an acceptable method of birth control from the Screening 1 Visit until 1 month after study completion. Acceptable methods include hormonal contraception (oral contraceptives, patch, implant, and injection), intrauterine devices, double barrier methods (e.g., vaginal diaphragm, vaginal sponge, condom, spermicidal jelly), sexual abstinence or a vasectomized partner. Women who are surgically sterile with documentation of such, or who are at least 1-year post-last menstrual period and > 55 years of age, are considered not to be of childbearing potential.

    E.4Principal exclusion criteria
    1.Have any level of low blood bicarbonate at either Screening Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
    2.Have had anuria, dialysis, acute kidney injury, history of acute renal insufficiency or known ≥ 30% increase in serum creatinine or known ≥ 30% acute or chronic decrease in eGFR in the 3 months prior to the Screening 1 Visit.
    3.Have chronic obstructive pulmonary disease (COPD) that is treated with chronic oral steroids, that requires the subject to be on oxygen, or that required hospitalization within the previous 6 months.
    4.Had heart failure with maximum New York Heart Association (NYHA) Class IV symptoms, or that required hospitalization with a primary cause of heart failure, during the preceding 6 months (see Append 3).
    5.Have had a heart or kidney transplant.
    Note: Patients on the cadaveric transplant list or being evaluated for a future living donor transplant may be enrolled.
    6.Planned initiation of renal replacement therapy (dialysis or transplantation) within 12 weeks following randomization.
    7.Have had a stroke or transient ischemic attack (TIA) within the 6 months prior to randomization.
    8.Have had a cardiac event within 12 weeks prior to randomization, including: myocardial infarction, acute coronary syndrome, coronary bypass grafting, percutaneous coronary intervention, valve procedure, inpatient or outpatient treatment for acute decompensated heart failure.
    9.Have been hospitalized for any reason during the 2 months prior to the Screening 1 Visit, other than for pre-planned diagnostic or minor invasive procedures. Note: Subjects who had major CV procedures or percutaneous cardiac procedures during this time frame are excluded, even if the procedures were pre planned.
    10.Have a history or current diagnosis of clinically significant diabetic gastroparesis (based on Investigator’s judgment) or a history of bariatric surgery.
    11.Have a history or current diagnosis of bowel obstruction, swallowing disorders, severe GI disorders, inflammatory bowel disease, major GI surgery, frequent diarrhea or active gastric/duodenal ulcers.
    12.Have liver enzyme (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) or total bilirubin values > 3 × the upper limit of normal (ULN) at Screening based on central laboratory measurements.
    13.Have a serum calcium ≤ 8.0 mg/dL at the Screening 1 Visit based on central laboratory measurement.
    14.Have a serum potassium value < 3.8 mEq/L or > 5.9 mEq/L at the Screening 1 or Screening 2 Visit.
    15.Have active cancer during the 1 year prior to Screening, other than non-melanoma skin cancer, or cancer that is currently being treated or will be treated during the study. Subjects with cancers that are being treated with hormonal therapy only may be permitted with approval of the Medical Monitor.
    16.Have received any investigational medication during the last month (28 days or ≥ 5 half-lives [if known], whichever is longer) preceding the Screening 1 Visit.
    17.Have used any of the following in the 14 days prior to the Screening 1 Visit: lanthanum carbonate, colesevelam, cholestyramine or sodium or calcium polystyrene sulfonate, calcium acetate, sevelamer, bixalomer, patiromer, and other polymeric binder drugs.
    18.Have had a change in doses (including starting or stopping treatment) in the 2 weeks prior to the Screening 1 Visit or during Screening Period to the following: calcium-containing supplements, such as calcium carbonate and calcium citrate; antacids; H2-blockers; proton pump inhibitors. See Section 5.9 for examples of specific drugs.
    19.Have had a change in doses (including starting or stopping treatment) in the 4 weeks prior to the Screening 1 Visit or during Screening Period to the following: sodium bicarbonate, potassium citrate, sodium citrate or other alkali therapy; diuretics; renin-angiotensin-aldosterone system [RAAS] inhibitors, such as angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor blockers [ARBs], aldosterone antagonists [AAs], mineralocorticoid receptor antagonists [MRAs]; non-ophthalmic carbonic anhydrase inhibitors. See Section 5.9 for examples of specific drugs.
    Note: For diuretics, dose changes of up to ± 50% relative to the average dose during the Screening Period are considered “stable”, and a dose change up to ± 50% between the Screening 1 Visit and the Baseline Visit is considered “stable”.
    20.Have a known allergy to placebo (microcrystalline cellulose).
    21.Inability to consume the study drug or otherwise comply with the protocol.
    22.Have, in the opinion of the Investigator, any medical condition, uncontrolled systemic disease or serious concurrent illness that would significantly decrease study compliance or jeopardize the safety of the subject or affect the validity of the study results.
    23.Have participated in a previous clinical study of TRC101.
    24.Currently breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy:
    Having a change from baseline (CFB) in blood bicarbonate ≥ 4mEq/L or having blood bicarbonate in the normal range (22 to 29 mEq/L).

    Safety:
    1. AEs, SAEs and withdrawal of the study treatment due to AE.
    2. Having met the high bicarbonate dose interruption criterion (confirmed > 30 mEq/L).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Efficacy:
    At the end of treatment (Week 12 Visit)

    Safety:
    1. At any time during the Treatment Period.
    E.5.2Secondary end point(s)
    Secondary Efficacy:
    CFB in blood bicarbonate.

    Exploratory Efficacy:
    1. CFB in the total score of the Kidney Disease and Quality of Life (KDQOL) Question 3 items (daily activities).
    2. CFB in repeated chair stand test duration.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of treatment (Week 12 Visit)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Croatia
    Georgia
    Hungary
    Serbia
    Slovenia
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 210
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-15
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