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    The EU Clinical Trials Register currently displays   35185   clinical trials with a EudraCT protocol, of which   5753   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-003955-50
    Sponsor's Protocol Code Number:D9480C00005
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-11-15
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-003955-50
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ENERGIZE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess whether ZS (Sodium Zirconium Cyclosilicate) added to standard of care  (insulin and glucose) is effective in treating elevated blood potassium concentration
    A.3.2Name or abbreviated title of the trial where available
    ENERGIZE
    A.4.1Sponsor's protocol code numberD9480C00005
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03337477
    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 SponsorAstraZeneca, AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca, AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018003369933
    B.5.6E-mailInformation.Center@astrazeneca.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 nameSodium zirconium cyclosilicate powder for oral suspension
    D.3.2Product code AZD7270
    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 INNSodium zirconium cyclosilicate
    D.3.9.1CAS number 24800-27-7
    D.3.9.2Current sponsor codeSodium zirconium cyclosilicate
    D.3.9.3Other descriptive nameAZD7270
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    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
    Hyperkalemia requiring urgent therapy (serum potassium more than or equal to 5.8mmol/L).
    E.1.1.1Medical condition in easily understood language
    High level of potassium in blood.
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10020646
    E.1.2Term Hyperkalaemia
    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 assess the effect of ZS vs placebo when added to insulin and glucose on the reduction of potassium at 4 hours after start of dosing
    E.2.2Secondary objectives of the trial
    - To assess the effect of ZS vs placebo when added to insulin and glucose on the response to therapy
    - To assess the effect of ZS vs placebo when added to insulin and glucose on the change in
    serum potassium at 1h and 2h after start of dosing
    - To assess the effect of ZS vs placebo when added to insulin and glucose on achieving normokalaemia
    -To assess the effect of ZS vs placebo when added to insulin and glucose on achieving S-K <5.5mmol/l and <6.0mmol/l
    -To assess the need for additional therapies for hyperkalaemia between ZS and placebo when added to insulin and glucose
    Safety Objectives:
    -To characterize the safety of ZS when added to insulin and glucose
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • ≥ 18 years of age at the time of signing the informed consent form.
    • S-K ≥ 5.8 mmol/L, as determined using an i-STAT device. Patients with S-K 5.8 or 5.9 mmol/L can be included only if treatment of the patient with insulin and glucose is in accordance with the local standard of care. S-K measured by local laboratory prior to insulin administration may replace S-K measured by i-STAT for assessment against this inclusion criterion for patients having received insulin before signing the informed consent form.
    E.4Principal exclusion criteria
    • Possible pseudohyperkalaemia as assessed by the investigator, e.g. secondary to hemolyzed blood specimen.
    • Hyperkalaemia caused by any condition for which a therapy directed against the underlying cause of hyperkalaemia would be a better treatment option than treatment with insulin and glucose. This includes, but is not limited to hyperkalaemia reasonably likely to be caused by physical injury, intoxication, pre-renal kidney failure, substance abuse, diabetic ketoacidosis and rhabdomyolysis.
    • Presence of any other acute or chronic medical condition which, in the opinion of the investigator, places the patient at undue risk due to the severity of illness or potentially jeopardizes patients' ability to follow study procedures in the acute setting. Patients having any acute or chronic medical condition other than hyperkalaemia that would alone require immediate treatment in the hospital setting at Visit 1. are not eligible for the study.
    • Dialysis session expected within 4h after randomization.
    • Treated with any therapy intended to lower S-K between arriving at the hospital and randomization during Visit 1. with exception of patients meeting the following criteria:
    - Treated with no more than one course of insulin since arriving at the hospital.
    - S-K measured by i-STAT device or local laboratory prior to administration of insulin. S-K must have met Inclusion criterion 4.
    - Reasonably likely to randomize, have screening and 0h assessments done, and dose the patient with ZS/placebo within 30 minutes of the start of administration of insulin.
    E.5 End points
    E.5.1Primary end point(s)
    Mean absolute change in S-K from baseline until 4h after start of dosing with ZS/placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    start of dosing untill 4h
    E.5.2Secondary end point(s)
    1. Fraction of patients responding to therapy with responders to therapy defined as
    • S-K <6.0mmol/L between 1 and 4h and S-K <5.0mmol/L at 4h
    AND
    • No additional therapy administered for hyperkalaemia from 0 to 4h with exception of the initial insulin treatment administered
    2.Mean absolute change in S-K from baseline to 1h and 2h after start of dosing with ZS/placebo
    3. The fraction of patients achieving normokalaemia 1, 2 and 4h after start of dosing ZS/placebo
    4. The fraction of patients achieving S-K <5.5mmol/l and <6.0mmol/l 1, 2, and 4h after start of dosing ZS/placebo
    5.The fraction of patients administered additional potassium lowering therapy due to hyperkalaemia from 0 to 4h. The considered therapies are:
    • 2nd dose of insulin
    • Beta-agonists
    • Diuretics
    • Dialysis
    • Sodium bicarbonate
    • Potassium binders
    6.Safety Endpoint:
    Adverse events (AEs) and serious AEs (SAEs)
    Changes in vital signs (VS), physical examinations, and ECGs
    Changes in clinical laboratory parameters, including assessment of hypokalaemia using S-K
    measurements and of hypoglycaemia using P-glucose measurements
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. between 0h and 4h, at 4h
    2. from baseline to 1h and 2h after starting the dose
    3.1h, 2h and 4h after start of dosing;
    4.1h, 2h, and 4h after start of dosing;
    5. from 0 to 4h
    6. from baseline untill study completion
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Denmark
    Italy
    Russian Federation
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Last visit of the Last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 27
    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 Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 132
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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