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    Summary
    EudraCT Number:2021-003527-14
    Sponsor's Protocol Code Number:D9480C00023
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-19
    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 ConcernedSpain - AEMPS
    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
    Estudio en fase IV, abierto, aleatorizado, del uso continuado de ciclosilicato de sodio y zirconio (CSZ) después del alta hospitalaria en participantes con nefropatía crónica tratados por hiperpotasemia
    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
    Estudio del uso continuado de ciclosilicato de sodio y zirconio (CSZ) después del alta hospitalaria
    A.3.2Name or abbreviated title of the trial where available
    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.3.9.3Other descriptive nameSODIUM ZIRCONIUM CYCLOSILICATE (SZC)
    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
    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.
    Pacientes con nefropatía crónica tratados por hiperpotasemia mientras están en el hospital, y establecer una dosis de mantenimiento de CSZ al alta.
    E.1.1.1Medical condition in easily understood language
    Hyperkalemia means that the potassium level in the blood is higher than normal
    Hiperpotasemia significa que el nivel de potasio en la sangre es más alto de lo normal
    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
    Evaluar la eficacia de continuar el tratamiento con CSZ como parte de los medicamentos en el momento del alta hospitalaria, en comparación con el tratamiento estándar, en el mantenimiento de la 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
    Evaluar el efecto de la continuación de la CSZ como parte de los medicamentos en el momento del alta hospitalaria, en comparación con el tratamiento estándar, en la reducción de la incidencia del criterio de valoración compuesto de ingresos hospitalarios o visitas al servicio de urgencias (SU) con HK como factor contribuyente, muerte por cualquier causa o uso de tratamiento de rescate para la HK.
    2. reducción de la incidencia del criterio de valoración compuesto de ingresos hospitalarios con HK como factor contribuyente, muerte por cualquier causa o uso de tratamiento de rescate para la HK.
    3. reducción de la incidencia de visitas al SU con HK
    4. reducción de la incidencia del criterio de valoración compuesto de ingresos hospitalarios o visitas al SU con HK como factor contribuyente o la muerte por cualquier causa
    5. reducción de la incidencia de ingresos hospitalarios con HK como factor contribuyente o la muerte por cualquier causa
    6. reducción de la incidencia de visitas al SU
    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 Deben tener 18 años o más en el momento de firmar el formulario de consentimiento informado
    2 Ingreso en el hospital (atención hospitalaria; directamente o desde el SU)
    3 Con:
    -NPC en estadio 3b a 5 diagnosticada
    o
    -TFGe <45 ml/min/1,73 m2 en el momento de la selección del estudio o en los 3 meses anteriores, según la ecuación de la Colaboración en epidemiología de la nefropatía crónica (CKD-EPI) (Levey et al, 2009). Nota: La raza/origen étnico no deben incluirse en el cálculo de la ecuación CKD-EPI.
    4 La medición de K+ registrada más reciente, ya sea para este ingreso o en la visita al SU que provocó este ingreso, debe estar entre 5,5 y 6,5 mmol/l, ambos inclusive
    5 Hombre o mujer
    6 Capaz de, y dispuesto a, dar el consentimiento informado firmado, tal como se describe en el Apéndice A, que incluye el cumplimiento de los requisitos y las restricciones que se enumeran en el formulario de consentimiento informado (FCI) y en este protocolo.
    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 Infarto de miocardio, accidente cerebrovascular, convulsiones o un acontecimiento trombótico/tromboembólico (p. ej., trombosis venosa profunda o embolia pulmonar, pero excluyendo trombosis de acceso vascular) en las 12 semanas anteriores a la selección
    2 Incapaz de tomar la mezcla de fármaco CSZ por vía oral
    3 Destinatario de, o con fecha programada para, un trasplante de riñón de donante vivo
    4 Con una esperanza de vida de menos de 6 meses
    5 Cualquier afección médica (incluida infección activa clínicamente significativa) que, en opinión del investigador o del promotor, pueda suponer un riesgo para la seguridad del participante en este estudio, lo que puede confundir las evaluaciones de la seguridad o la eficacia y poner en peligro la calidad de los datos, o pueda interferir con la participación en el estudio
    6 Presencia de arritmias cardíacas o defectos de la conducción que requieran tratamiento inmediato
    7 Intervalo QT corregido por el método Fridericia (QTcF) >550 ms
    8 Antecedentes de prolongación del intervalo QT asociado con otros medicamentos que requirieron la interrupción de dicho medicamento.
    9 Síndrome de QT largo congénito
    10 Fibrilación auricular sintomática o no controlada a pesar del tratamiento, o taquicardia ventricular sostenida asintomática. Están permitidos los participantes con fibrilación auricular controlada con medicación.
    11 Indicios de enfermedad por coronavirus 2019 (COVID-19) en las 2 semanas anteriores a la selección (véase el Apéndice C)
    12 Antecedentes de abuso de alcohol o drogas en los 2 años anteriores a la selección
    13 Tratamiento continuado con cualquier quelante de K en el momento del ingreso de referencia en el hospital (se permite el inicio del tratamiento con CSZ durante la visita al SU inmediatamente anterior al ingreso de referencia en el hospital)
    14 Tratamiento sustitutivo renal, incluida hemodiálisis crónica y diálisis peritoneal
    15 Participación en otro estudio clínico con un producto en fase de investigación (PEI) administrado durante el mes previo a la selección. Nota: Los participantes vacunados con una vacuna contra la COVID-19 mientras aún esté bajo la Autorización de Uso de Emergencia no se excluirán del estudio.
    16 Hipersensibilidad conocida a CSZ o a cualquiera de los excipientes del producto.
    17 Participación en la planificación y/o realización del estudio (aplicable al personal de AstraZeneca y/o al personal del centro del estudio).
    18 Determinación por parte del investigador de que el participante no debe participar en el estudio si es poco probable que cumpla con los procedimientos, las restricciones y los requisitos del estudio.
    19 Aleatorización previa en el presente estudio
    20 Solo para mujeres: las mujeres en edad fértil (MEF; es decir, aquellas que no están esterilizadas química o quirúrgicamente o que no son posmenopáusicas) que no están dispuestas a utilizar uno de los métodos anticonceptivos descritos a continuación, desde el momento de la firma del consentimiento informado a lo largo del estudio y a las 4 semanas siguientes:
    a Anticonceptivos hormonales combinados (que contengan estrógenos y gestágeno) asociados a inhibición de la ovulación: orales, intravaginales o transdérmicos.
    b Anticonceptivos hormonales solo de gestágenos asociados a inhibición de la ovulación: orales, inyectables o implantables.
    c Dispositivo intrauterino (DIU).
    d Sistema intrauterino (SIU) liberador de hormonas.
    e Oclusión tubárica bilateral.
    f Pareja vasectomizada (la pareja vasectomizada es un método anticonceptivo altamente eficaz siempre que se trate de la única pareja sexual de la MEF participante y que se haya evaluado el éxito quirúrgico en la pareja vasectomizada.
    (g) Abstinencia sexual: se considera un método anticonceptivo altamente eficaz solamente si se define como la abstinencia de mantener relaciones heterosexuales durante todo el periodo de riesgo asociado a los tratamientos del estudio. Debe evaluarse la fiabilidad de la abstinencia sexual en relación con la duración estudio clínico y el estilo de vida preferido y habitual del participante.
    21 Para MEF solamente: mujeres con resultado positivo en una prueba de embarazo en la selección O mujeres en período de lactancia.
    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.
    Aparición (sí/no) de NK (potasio [K+] entre 3,5 y 5,0 mmol/l, ambos inclusive) 180 días después del alta hospitalaria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 180 days post-discharge
    Hasta 180 días después del alta hospitalaria.
    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
    Tiempo hasta la primera incidencia:
    1. ingresos hospitalarios o visitas al SU con HK como factor contribuyente, muerte por cualquier causa o uso de tratamiento de rescate para la HK en cualquier momento
    2. primera incidencia de ingreso hospitalario con HK como factor contribuyente, muerte por cualquier causa o uso de tratamiento de rescate para la HK
    3. de visitas al SU con HK como factor contribuyente, muerte por cualquier causa o uso de tratamiento de rescate para la HK
    4,5 y 6: cualquiera de los componentes del resultado en el punto 1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At any time post-discharge up to 180 days.
    En cualquier momento después del alta hospitalaria hasta los 180 días.
    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
    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 concerned6
    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 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
    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
    UVUP
    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 months6
    E.8.9.1In the Member State concerned days6
    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.
    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 Decision2021-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-08
    P. End of Trial
    P.End of Trial StatusOngoing
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