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    Summary
    EudraCT Number:2017-003955-50
    Sponsor's Protocol Code Number:D9480C00005
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    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)
    Studio di fase II, multicentrico, randomizzato, in doppio cieco, controllato da placebo per valutare un trattamento di normalizzazione del potassio che include Sodio Zirconio Ciclosilicato (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
    Studio per valutare se ZS (Sodio Zirconio Ciclosilicato) aggiunto alla terapia standard (insulina e glucosio) ¿ efficace nel trattamento di elevate concentrazioni di potassio nel sangue
    A.3.2Name or abbreviated title of the trial where available
    ENERGIZE
    ENERGIZE
    A.4.1Sponsor's protocol code numberD9480C00005
    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 SPA
    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 Addressna
    B.5.3.2Town/ cityna
    B.5.3.3Post codena
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 800 336 9933
    B.5.5Fax number0
    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 namezirconium cyclosilicate
    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.3.10 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    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 6.0).
    Ipercaliemia che richiede terapia d'urgenza (potassio nel siero maggiore o uguale a 6.0)
    E.1.1.1Medical condition in easily understood language
    High level of potassium in blood.
    Elevato livello di potassio nel sangue
    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 21.1
    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
    Valutare l'effetto del SZ rispetto al placebo somministrati in aggiunta a insulina e glucosio sulla riduzione del potassio a 4 ore dalla somministrazione
    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
    -Valutare l'effetto del SZ rispetto a placebo in combinazione con insulina e glucosio sulla risposta alla terapia
    - Valutare l'effetto del SZ rispetto a placebo in combinazione con insulina e glucosio sulle variazioni di potassio sierico a 1 ora e 2 ore dalla somministrazione
    - Valutare l'effetto del SZ rispetto al placebo in combinazione con insulina e glucosio sul raggiungimento della normocaliemia
    -Valutare l'effetto del SZ rispetto al placebo in combinazione con insulina e glucosio sul raggiungimento di valori di potassio sierico <5.5mmol/l e <6mmol/l
    -Valutare la differenza nella necessit¿ di somministrare terapie aggiuntive per l'ipercaliemia tra il SZ e il placebo in aggiunta a insulina e glucosio
    Obiettivi di Sicurezza
    - Caratterizzare la sicurezza del SZ quando viene somministrato in combinazione a insulina e glucosio
    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.
    • Whole blood potassium =6.0 mmol/L, as determined using an i-STAT device.
    • = 18 anni di età al momento della firma del consenso informato.
    • Potassio nel sangue =6.0 mmol/L, come determinato usanto uno strumento iSTAT.
    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 hyperkalaemia reasonably likely to be caused by physical injury, intoxication, pre-renal kidney failure, substance abuse, diabetic ketoacidosis, and rhabdomyolysis.
    • Dialysis session scheduled or anticipated within 4h after randomization.
    • Treated with any therapy intended to lower S-K between arriving at the hospital and randomization during Visit 1.
    • Possibile pseudoipercaliemia valutata dal medico di studio; ad esempio dovuta a campioni di sangue emolisati.
    • Ipercaliemia causata da qualsiasi altra condizione per cui un trattamento diretto alla causa dell'ipercaliemia costituisce una terapia migliore rispetto al trattamento con insulina e glucosio. Questo include casi in cui è ragionevolmente probabile che l'ipercaliemia sia causata da lesioni fisiche, intossicazione, insuficienza renale, abuso di sostanze, chetoacidosi diabetica e rabdomiolisi.
    • Sessioni di dialisi programmate o anticipate entro le 4 ore dalla randomizzazione.
    • Trattamento con qualsiasi terapia somministrata con lo scopo di ridurre la concentrazione di potassio sierico tra l'arrivo in ospedale e la randomizzazione effettuata durante la visita 1.
    E.5 End points
    E.5.1Primary end point(s)
    Mean absolute change in S-K from baseline until 4h after start of dosing
    Variazione media assoluta del potassio sierico dal baseline a 4 ore dall’inizio della somministrazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    start of dosing until 4h
    dall'inizio della somministrazione fino a 4 ore dopo la prima dose
    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 at 0h
    ; 2.Mean absolute change in S-K from baseline to 1 and 2h after start of
    dosing; 3. The fraction of patients achieving normokalaemia 1, 2 and 4h after
    start of dosing; 4. The fraction of patients achieving S-K <5.5mmol/l and <6.0mmol/l 1,
    2, and 4h after start of dosing; 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; 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
    1. Frazione di pazienti che risponde alla terapia con pazienti responders definiti come:

    ¿ Potassio sierico (S-K) <6.0 mmol/L tra 1 e 4 ore e S-K<5.0 mmol/L a 4 ore
    E
    ¿ Nessun trattamento addizionale per l¿ipercaliemia da da 0 a 4 ore ad eccezione dell¿iniziale trattamento con insulina somministrata al momento 0
    ; 2. Media della modifica assoluta di potassio sierico dal valore iniziale a 1 e 2 ore dopo l¿inizio della somministrazione; 3. La frazione di pazienti che raggiungono la normocaliemia 1, 2 e 4 ore dopo l¿inizio della somministrazione; 4. La frazione di pazienti che raggiungono valori di S-K 5.5mmol/l e <6.0mmol/l 1, 2 e 4 ore dopo l¿inizio della somministrazione; 5. La frazione di pazienti a cui viene somministrata una ulteriore terapia per abbassare il livello del potassio dovuto a ipercaliemia da 0 a 4 ore. Le terapie considerate sono:
    ¿ Seconda dose di insulina
    ¿ Beta agonisti
    ¿ Diuretici
    ¿ Dialisi
    ¿ Bicarbonato di Sodio
    ; 6. Endpoint di Sicurezza
    ¿ Eventi Avversi (Adverse Events, AE) e Eventi Avversi Seri (Serious Adverse Events, SAE)
    ¿ Cambiamenti nei segni vitali, nella visita medica e nell¿ECG
    ¿ Cambiamenti nei parametri di laboratorio, inclusa l¿analisi dell¿ipocaliemia usando i valori di S-K
    ¿ Misura dell¿ipocaliemia usando la misura di P-glucosio
    E.5.2.1Timepoint(s) of evaluation of this end point
    between 0h and 4h, at 4h; 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
    tra 0 e 4 ore, a 4 ore; dall'inizio a 1 ora e 2 ore dopo l'inzio della somministrazione; 1 ora, 2 ore e 4 ore dopo l'inizio della somministrazione; 1 ora, 2 ore e 4 ore dopo l'inizio della somministrazione; da 0 a 4 ore; dall'inizio fino al completamento dello studio
    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 concerned8
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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: 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 state36
    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
    Nessuno
    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 Decision2018-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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