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    Summary
    EudraCT Number:2021-003527-14
    Sponsor's Protocol Code Number:D9480C00023
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-27
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-003527-14
    A.3Full title of the trial
    An Open-Label, Randomised, Phase 4 Study of Continuing Sodium Zirconium Cyclosilicate (SZC) after Discharge in Participants with Chronic Kidney Disease treated for Hyperkalaemia
    Studio in aperto, randomizzato, di fase 4 sulla prosecuzione del ciclosilicato di sodio zirconio (SZC) dopo la dimissione nei partecipanti con malattia renale cronica trattati per iperkaliemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Continuing Sodium Zirconium Cyclosilicate (SZC) after discharge study
    Studio di prosecuzione del ciclosilicato di sodio zirconio (SZC) dopo la dimissione
    A.3.2Name or abbreviated title of the trial where available
    CONTINUITY
    CONTINUITY
    A.4.1Sponsor's protocol code numberD9480C00023
    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 AB
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike
    B.5.3.2Town/ cityWilmington DE
    B.5.3.3Post code19803
    B.5.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name Lokelma
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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
    D.3.2Product code [SZC]
    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 242800-27-7
    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) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Chronic Kidney Disease treated for Hyperkalaemia whilst in hospital, who are normokalemic and established on maintenance dose of SZC at discharge.
    pazienti malattia renale cronica (MRC) trattati per iperkaliemia durante il ricovero in ospedal, che sono normokalemici e stabilizzati con dose di mantenimento di SZC fino alla dimissione.
    E.1.1.1Medical condition in easily understood language
    Hyperkalemia means that the potassium level in the blood is higher than normal
    Iperkaliemia significa che il livello di potassio nel sangue è più alto del normale
    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 evaluate the efficacy of continuing SZC as part of the discharge medications, compared to SoC, in maintaining NK
    Valutare l’efficacia della prosecuzione di SZC nell’ambito dei farmaci somministrati alla dimissione, rispetto a SoC, nel mantenimento della NK.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC:
    1. in reducing the incidence of the composite outcome of hospital admissions or ED visits with HK as a contributing factor, all-cause death, or use of rescue-therapy for HK
    2. in reducing the incidence of the composite outcome of hospital admissions with HK as a contributing factor, all-cause death, or use of rescue therapy for HK
    3. in reducing the incidence of ED visits with HK as a contributing factor, all-cause death, or use of rescue therapy for HK
    4. in reducing the incidence of the composite outcome of hospital admissions or ED visits with HK as a contributing factor or all-cause death
    5. in reducing the incidence of hospital admissions with HK as a contributing factor or all-cause death
    6. in reducing the incidence of ED visits with HK as a contributing factor or all-cause death
    Valutare l’effetto della prosecuzione di SZC nell’ambito dei farmaci somministrati alla dimissione, rispetto a SoC:
    1. nel ridurre l’incidenza dell’esito composito dei ricoveri ospedalieri o delle visite al pronto soccorso (PS) con l’HK come fattore contribuente, del decesso per qualsiasi causa o dell’uso di terapia di soccorso per l’HK.
    2. Valutare l’effetto della prosecuzione di SZC nell’ambito dei farmaci somministrati alla dimissione, rispetto a SoC, nel ridurre l’incidenza dell’esito composito dei ricoveri ospedalieri con l’HK come fattore contribuente, del decesso per tutte le cause o dell’uso di terapia di soccorso per l’HK.
    3. Valutare l’effetto della prosecuzione di SZC nell’ambito dei farmaci somministrati alla dimissione, rispetto a SoC, nel ridurre l’incidenza delle visite in PS con l’HK come fattore contribuente, del decesso per tutte le cause o dell’uso di terapia di soccorso per l’HK.
    4. [...] Si prega di far riferimento al protocollo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Must be 18 years of age or older, at the time of signing the informed consent
    2 Admitted to hospital (inpatient care; directly or from ED)
    3 With:
    - diagnosed stage 3b to 5 CKD
    And/or
    - eGFR < 45 ml/min/1.73 m2 at, or within 3 months of, study screening, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Levey et al, 2009). Note: Race/ethnicity should not be included in CKD-EPI equation calculation.
    4 Most recent recorded K+ measurement, either for this admission or at ED visit leading to this admission, should be between 5.5 and 6.5 mmol/L, inclusive
    5 Male or female
    6 Capable and willing of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
    1 Must be 18 years of age or older, at the time of signing the informed consent
    2 Admitted to hospital (inpatient care; directly or from ED)
    3 With:
    - diagnosed stage 3b to 5 CKD
    And/or
    - eGFR < 45 ml/min/1.73 m2 at, or within 3 months of, study screening, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Levey et al, 2009). Note: Race/ethnicity should not be included in CKD-EPI equation calculation.
    4 Most recent recorded K+ measurement, either for this admission or at ED visit leading to this admission, should be between 5.5 and 6.5 mmol/L, inclusive
    5 Male or female
    6 Capable and willing of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
    E.4Principal exclusion criteria
    1 Myocardial infarction, stroke, seizure, or a thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 12 weeks prior to screening
    2 Unable to take oral SZC drug mix
    3 Recipient of or scheduled date for living donor kidney transplant
    4 With a life expectancy of less than 6 months
    5 Any medical condition (including active, clinically significant infection) that, in the opinion of the investigator or sponsor, may pose a safety risk to the participant in this study, which may confound safety or efficacy assessments and jeopardise the quality of data, or may interfere with study participation
    6 Presence of cardiac arrhythmias or conduction defects that require immediate treatment
    7 QT interval corrected by the Fridericia method (QTcF) > 550 msec
    8 History of QT prolongation associated with other medications that required discontinuation of that medication
    9 Congenital long QT syndrome
    10 Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participant with atrial fibrillation controlled by medication is permitted.
    11 Evidence of Coronavirus disease 2019 (COVID-19) within 2 weeks prior to screening (see Appendix C)
    12 History of alcohol or drug abuse within 2 years prior to screening
    13 Ongoing treatment with any K-binder at index hospital admission (initiation of SZC during ED visit immediately preceding the index hospital admission is allowed)
    14 Renal replacement therapy, including chronic haemodialysis and peritoneal dialysis
    15 Participation in another clinical study with an investigational product (IP) administered during the month before screening. Note: Participant vaccinated with COVID-19 vaccine whilst still under Emergency Use Utilisation will not be excluded from the study.
    16 Known hypersensitivity to SZC or any of the excipients of the product
    17 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
    18 Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements
    19 Previous randomisation in the present study
    20 For women only: Women of child-bearing potential (WOCBP; ie, those who are not chemically or surgically sterilised or who are not postmenopausal) who are not willing to use one of the methods of contraception described hereafter, from the time of signing the informed consent throughout the study and 4 weeks thereafter:
    (a) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
    (b) Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
    (c) Intrauterine device (IUD)
    (d) Intrauterine hormone-releasing system (IUS)
    (e) Bilateral tubal occlusion
    (f) Vasectomised partner (vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP participant and that the vasectomised partner has received medical assessment of the surgical success
    (g) Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
    21 For WOCBP only: Women who have a positive pregnancy test at screening OR women who are breastfeeding.
    1 Myocardial infarction, stroke, seizure, or a thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 12 weeks prior to screening
    2 Unable to take oral SZC drug mix
    3 Recipient of or scheduled date for living donor kidney transplant
    4 With a life expectancy of less than 6 months
    5 Any medical condition (including active, clinically significant infection) that, in the opinion of the investigator or sponsor, may pose a safety risk to the participant in this study, which may confound safety or efficacy assessments and jeopardise the quality of data, or may interfere with study participation
    6 Presence of cardiac arrhythmias or conduction defects that require immediate treatment
    7 QT interval corrected by the Fridericia method (QTcF) > 550 msec
    8 History of QT prolongation associated with other medications that required discontinuation of that medication
    9 Congenital long QT syndrome
    10 Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participant with atrial fibrillation controlled by medication is permitted.
    11 Evidence of Coronavirus disease 2019 (COVID-19) within 2 weeks prior to screening (see Appendix C)
    12 History of alcohol or drug abuse within 2 years prior to screening
    13 Ongoing treatment with any K-binder at index hospital admission (initiation of SZC during ED visit immediately preceding the index hospital admission is allowed)
    14 Renal replacement therapy, including chronic haemodialysis and peritoneal dialysis
    15 Participation in another clinical study with an investigational product (IP) administered during the month before screening. Note: Participant vaccinated with COVID-19 vaccine whilst still under Emergency Use Utilisation will not be excluded from the study.
    16 Known hypersensitivity to SZC or any of the excipients of the product
    17 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
    18 Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements
    19 Previous randomisation in the present study
    20 For women only: Women of child-bearing potential (WOCBP; ie, those who are not chemically or surgically sterilised or who are not postmenopausal) who are not willing to use one of the methods of contraception described hereafter, from the time of signing the informed consent throughout the study and 4 weeks thereafter:
    (a) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
    (b) Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
    (c) Intrauterine device (IUD)
    (d) Intrauterine hormone-releasing system (IUS)
    (e) Bilateral tubal occlusion
    (f) Vasectomised partner (vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP participant and that the vasectomised partner has received medical assessment of the surgical success
    (g) Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
    21 For WOCBP only: Women who have a positive pregnancy test at screening OR women who are breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence (yes/no) of NK (K+ between 3.5 and 5.0 mmol/L, inclusive) at 180 days post-discharge.
    Occorrenza (sì/no) della NK (potassio [K+] tra 3,5 e 5,0 mmol/l, inclusi) a 180 giorni dopo la dimissione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 180 days post-discharge
    a 180 giorni dopo la dimissione.
    E.5.2Secondary end point(s)
    Time to first occurrence of:
    1. hospital admissions or ED visits with HK as a contributing factor, use of rescue therapy for HK, or all-cause death (composite outcome)
    2. hospital admission with HK as a contributing factor, all-cause death, or use of rescue therapy for HK
    3. ED visits with HK as a contributing factor, all-cause death, or use of rescue therapy for HK
    4, 5 and 6: either component of the composite outcome in point 1
    Tempo alla prima occorrenza di:
    1. ricoveri ospedalieri o visite in PS con l’HK come fattore contribuente, al decesso per qualsiasi causa o all’uso di terapia di soccorso per l’HK in qualsiasi momento successivo alla dimissione fino a 180 giorni.
    2. ricovero ospedaliero con l’HK come fattore contribuente, al decesso per qualsiasi causa o all’uso di terapia di soccorso per l’HK in qualsiasi momento successivo alla dimissione fino a 180 giorni.
    3. di visite al PS con l’HK come fattore contribuente, al decesso per qualsiasi causa o all’uso di terapia di soccorso per l’HK in qualsiasi momento successivo alla dimissione fino a 180 giorni.
    4, 5 e 6. di uno dei componenti dell’esito composito in qualsiasi momento successivo alla dimissione fino a 180 giorni.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At any time post-discharge up to 180 days.
    In qualsiasi momento dopo la dimissione fino a 180 giorni.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Local standard of care
    Local standard of care
    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 EEA24
    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
    Belgium
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days6
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 224
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 337
    F.4.2.2In the whole clinical trial 344
    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)
    No intervention will follow the end of the study. Decision to continue on SZC treatment or SoC will be at investigator's discretion.
    Nessun intervento seguirà la fine dello studio. La decisione di continuare il trattamento con SZC o SoC sarà a discrezione dello sperimentatore.
    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 Decision2021-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
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