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    Summary
    EudraCT Number:2018-001303-36
    Sponsor's Protocol Code Number:TRCA-303
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-09-06
    Trial 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2018-001303-36
    A.3Full title of the trial
    A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis
    3b. fázisú, randomizált, kettÅ‘s vak, placebo kontrollos vizsgálat a TRC101 hatásosságának és biztonságosságának értékelésére a krónikus vesebetegség progressziójának késleltetésében metabolikus acidózisos betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study with patients who have increased acid in their blood because of chronic kidney disease that is testing if the experimental drug TRC101, compared to placebo (a substance that does not contain medicine), is safe and if it slows down worsening of kidney disease.
    A.3.2Name or abbreviated title of the trial where available
    VALOR-CKD
    A.4.1Sponsor's protocol code numberTRCA-303
    A.5.4Other Identifiers
    Name:IND numberNumber:125832
    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
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 415988 5120
    B.5.5Fax number+1 4155921601
    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
    Chronic kidney disease
    E.1.1.1Medical condition in easily understood language
    Longstanding kidney disease
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary 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 effect of TRC101 on the progression of chronic kidney disease and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    DXA sub-study
    Dual energy x-ray absorptiometery (DXA) scans will be performed in a
    subset of subjects (approximately 200 to 400) to evaluate bone mineral density and trabecular bone score. These subjects will be enrolled from a subset of sites who have qualified DXA facilities if they consent to
    undergo the scans.
    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, inclusive, at Screening 1 Visit.
    3. The mean of two Screening eGFR measurements, drawn at least 2 weeks apart and both within 6 weeks of the first day of Part A, is 20 to 40 mL/min/1.73m2, inclusive, calculated using the CKD-EPI equation as reported by the central laboratory.
    • Note: If more than two eGFR values were measured at the central laboratory during the Screening Period, the Screening eGFR will be based on the most recent two values that are at least 2 weeks apart and within 6 weeks of the first day of Part A.
    Enrollment of patients with Screening eGFR in the range 15 to 20 mL/min/1.73m2 may be allowed in the future with notification to the sites by Tricida and will not require a protocol amendment. Subjects with a Screening eGFR value in the range of 15 to <20 mL/min/1.73m2 may not be enrolled until Tricida has authorized this change in writing.
    4. Have stable renal function as defined by eGFR Screening values that are not different by > 20% (the higher of the two Screening eGFR values will be used as the denominator to calculate the 20% allowable difference).
    • Note: If more than two eGFR values were measured at the central laboratory during the Screening Period, the first and last values must be used for calculation of the allowable eGFR difference.
    5. Based on onsite measurement using an i STAT point of care device, have three serum bicarbonate values, each ≥ 2 weeks apart from each other and all within 6 weeks of the A1 Visit, in the range from 12 to 20 mEq/L, inclusive. One of these three values must be from the A1 Visit, pre-dose.
    One same-day retest using the i-STAT point of care device is allowed from Screening 1 Visit through the A1 Visit.
    Subjects with Baseline Bicarbonate (defined as the average of the serum bicarbonate values at Screening 1, Screening 2 and the A1 Visit [predose]) values of 12 to 18 mEq/L are eligible without restriction. Once approximately half of study subjects have been randomized with Baseline Bicarbonate > 18 to 20 mEq/L, randomization may be closed to additional subjects with Baseline Bicarbonate in this range.
    6. Mean systolic and diastolic blood pressure (determined as the average of three replicates) must be < 160/92 mmHg at the Screening 2 Visit.
    7. Receiving treatment with an ACE inhibitor and/or ARB at the maximum tolerated (for the individual subject) dose within the country-specific labeled dose range, without adjustments, for ≥ 4 weeks prior to the Screening 1 Visit and during the Screening Period. The maximum tolerated dose for an individual subject may be less than the maximum labeled dose or may be zero if the medical reason is documented.
    Subjects not treated with an ACE inhibitor or ARB must be approved by the Medical Monitor following a review of the medical justification.
    Non-diabetic subjects with urine ACR < 30 mg/g (< 3.39 mg/mmol) are not required to be receiving treatment with an ACE inhibitor and/or ARB.
    8. If receiving an oral alkali supplement, the dose must be stable for ≥ 2 weeks prior to Screening 1 Visit and during the Screening Period.
    If not receiving alkali treatment, there must be no such treatment within the 2 weeks prior to Screening 1 Visit or during the Screening Period.
    9. Have a hemoglobin A1c (HbA1c) value of ≤ 11.0% (0.11 fraction; 97 mmol/mol) at the Screening 1 Visit (based on central laboratory measurement).
    10. Have adequate peripheral venous access for blood draws.
    11. Women who are of childbearing potential must have negative pregnancy tests at the Screening 1 and Part B Day 1 Visits and be willing to use an acceptable method of birth control from the Screening 1 Visit until 1 week after study drug 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.

    Inclusion Criterion for Randomization:
    1. Have an increase from Baseline Bicarbonate of ≥ 4 mEq/L or have a serum bicarbonate value that is ≥ 22 mEq/L based on an i-STAT point of care measurement during Part A.
    E.4Principal exclusion criteria
    1. Have any level of low serum 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, or acute kidney injury/acute renal failure 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 during the 3 months prior to the Screening 1 Visit.
    5. Had a heart, liver or kidney transplant.
    Note: Subjects on the cadaveric transplant list or being evaluated for a future living donor transplant may be enrolled.
    6. Have planned initiation of renal replacement (RRT) therapy (dialysis or transplantation) within 6 months following randomization.
    7. Have had a stroke or transient ischemic attack within the 6 months prior to Screening 1 Visit.
    8. Have had a cardiac event within 3 months prior to Screening 1 Visit, 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 (e.g., placement of dialysis access).
    Note 1: Subjects who had major cardiovascular procedures or percutaneous cardiac interventional or therapeutic procedures during this time frame are excluded, even if the procedures were pre-planned.
    Note 2: Subjects hospitalized during this time frame for <48 hours or for self-limited conditions (e.g., hypoglycemia, hyperkalemia, nausea) may be enrolled with approval of the Medical Monitor.
    10. Have an ileostomy or colostomy or have had a bowel resection or bariatric surgery. Subjects who have had gastric lap band procedures (no gastric resection) are allowed.
    11. Have liver enzyme (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) or total bilirubin values > 3× the upper limit of normal (ULN) at the Screening 2 Visit based on central laboratory measurements.
    12. Have a corrected serum calcium < 8.0 mg/dL (80 mg/L; 2 mmol/L) at the Screening 1 Visit, based on central laboratory measurement.
    13. Have active cancer during the 1 year prior to the Screening 1 Visit or cancer that is currently being treated or will be treated during the study, other than non-melanoma skin cancer or low-grade cervical carcinoma. Subjects with cancers that are being treated with hormonal therapy only may be permitted with approval of the Medical Monitor.
    14. Have received any investigational drug during the last month (28 days or ≥ 5 half-lives [if known], whichever is longer) preceding the Screening 1 Visit or during Screening Period.
    15. Have a known allergy to placebo (microcrystalline cellulose).
    16. Have an inability to consume the study drug or otherwise comply with the protocol.
    17. Has received cytotoxic therapy, immunosuppressive therapy, or other immunotherapy for renal disease within 6 months prior to the Screening 1 Visit or during the Screening Period.
    Note: Glucocorticoid use is allowed.
    18. Have a history of alcoholism or drug/chemical abuse, as defined by The Diagnostic and Statistical Manual of Mental Disorders (DSM-5), within 6 months prior to the Screening 1 Visit.
    19. 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 interpretability of the subject’s data.
    20. Participated (i.e., was randomized) in Study TRCA-301.
    21. Are pregnant or currently breastfeeding.

    Exclusion Criteria for Randomization:
    1. Have a confirmed eGFR decline of ≥ 40% from baseline.
    2. Have received dialysis or a kidney transplant during Part A.
    3. Are pregnant or currently breastfeeding.
    4. Have, in the opinion of the Investigator, significant non-compliance with study requirements during Part A or 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 interpretability of the subject’s data.
    E.5 End points
    E.5.1Primary end point(s)
    Progression of chronic kidney disease, defined by time to first occurrence of any event in the composite endpoint consisting of the following as adjudicated by the independent blinded Clinical Endpoint Adjudication Committee (CEAC):
    • A confirmed ≥ 40% reduction in eGFR
    • End-stage renal disease (ESRD)
    • Renal death
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time to first occurrence of any component of the composite endpoint as adjudicated by an independent blinded CEAC.
    E.5.2Secondary end point(s)
    1. Time to ESRD
    2. eGFR slope
    3. Change from baseline in the total score of the KDQOL Physical Functioning Survey at the end of treatment or last measurement prior to initiation of renal replacement therapy (RRT), whichever occurs first
    4. Time to first occurrence of the primary composite endpoint or cardiovascular (CV) death
    5. Frequency of all-cause hospitalization
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Time to occurrence of ESRD
    2. At end of treatment
    3. At end of treatment or last measurement prior to initiation of RRT, whichever occurs first
    4. Time to first occurrence of primary composite endpoint or CV death
    5. At end of treatment
    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 Yes
    E.8.1.7.1Other trial design description
    This study includes a single-blind period of 4-8 weeks and a double-blind period of approx 3.5 years
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA158
    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
    Albania
    Argentina
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Czech Republic
    France
    Georgia
    Germany
    Hong Kong
    Hungary
    Israel
    Italy
    Korea, Republic of
    Macedonia, the former Yugoslav Republic of
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Poland
    Portugal
    Romania
    Serbia
    Singapore
    Slovakia
    Spain
    Taiwan
    Ukraine
    United Kingdom
    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
    The point in time when all subjects who are required to complete and
    likely to complete the 2-Week Post-Treatment Visit have done so.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1000
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 2000
    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 Decision2018-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-30
    P. End of Trial
    P.End of Trial StatusOngoing
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