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    Summary
    EudraCT Number:2018-005030-38
    Sponsor's Protocol Code Number:PAT-CR-302
    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:2019-08-09
    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 number2018-005030-38
    A.3Full title of the trial
    A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)
    Estudio multicéntrico, doble ciego, controlado con placebo, de retirada aleatorizada, con grupos paralelos, de patirómero para el manejo de la hiperpotasemia en pacientes que reciben medicamentos inhibidores del sistema renina-angiotensina-aldosterona (iSRAA) para el tratamiento de la insuficiencia cardíaca (DIAMOND)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A placebo controlled Study of Patiromer for the Management of high potassium serum levels in Subjects Receiving a certain group of medications called Renin-Angiotensin-Aldosterone System Inhibitor for treatment of Heart failure.
    Estudio controlado con placebo de patirómero para el manejo de la hiperpotasemia en pacientes que reciben un grupo de medicamentos llamados inhibidores del sistema renina-angiotensina-aldosterona para el tratamiento de la insuficiencia cardíaca
    A.3.2Name or abbreviated title of the trial where available
    DIAMOND
    A.4.1Sponsor's protocol code numberPAT-CR-302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03888066
    A.5.4Other Identifiers
    Name:IND numberNumber:075615
    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 SponsorRelypsa, Inc., a Vifor Company
    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 supportRelypsa, Inc a Vifor Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRelypsa, Inc.
    B.5.2Functional name of contact pointExec. Medical Director
    B.5.3 Address:
    B.5.3.1Street Address100 Cardinal Way
    B.5.3.2Town/ cityRedwood City
    B.5.3.3Post code94063 (CA)
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018447359772
    B.5.5Fax number0016507796389
    B.5.6E-maildgarza@relypsa.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 Veltassa®
    D.2.1.1.2Name of the Marketing Authorisation holderVifor Fresenius Medical Care Renal Pharma France for Europe and Relypsa, Inc. for USA
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePatiromer
    D.3.2Product code RLY5016
    D.3.4Pharmaceutical form 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 INNPatiromer for oral suspension
    D.3.9.2Current sponsor codeRLY5016
    D.3.9.3Other descriptive namePATIROMER
    D.3.9.4EV Substance CodeSUB182272
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8.4
    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 placeboOral 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
    Management of hyperkalemia due to renin-angiotension-aldosterone system medications in patients treated for heart failure.
    Manejo de la hiperpotasemia por medicamentos inhibidores del sistema renina-angiotensina-aldosterona en pacientes tratados por insuficiencia cardíaca
    E.1.1.1Medical condition in easily understood language
    Serum potassium levels increase in patients with heart failure.
    Niveles altos de potasio en suero en pacientes con insuficiencia cardíaca
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10005725
    E.1.2Term Blood potassium increased
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if patiromer treatment of subjects who developed hyperkalemia while receiving RAASi medications will result in continued use of RAASi medications in accordance with heart failure (HF) treatment guidelines and thereby decrease the occurrence of the combined endpoint of cardiovascular (CV) death and CV hospitalization events compared with placebo treatment.
    Determinar si el tratamiento con patirómero en sujetos que hayan desarrollado hiperpotasemia mientras recibían medicamentos iSRAA provocará la continuación del uso de medicamentos iSRAA de acuerdo con las directrices para el tratamiento de la insuficiencia cardíaca (IC) y, por lo tanto, reducir la incidencia del criterio de valoración combinado de episodios de muerte cardiovascular (CV) y acontecimientos de hospitalización CV en comparación con el tratamiento con placebo.
    E.2.2Secondary objectives of the trial
    Not applicable.
    No aplicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject provides written informed consent prior to study participation
    2. Age at least 18 years or greater
    3. History of New York Heart Association (NYHA) Class II–IV HF
    4. Left ventricular ejection fraction <40%, measured by any echocardiographic,
    radionuclide, or computerized tomography method in the last 12 months without
    subsequent measured ejection fraction ≥40% during this interval)
    5. Receiving any dose of a beta blocker (BB) for the treatment of HF or unable to
    tolerate BB (reason documented)
    6.Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at Screening
    (based on a single local laboratory calculation using the Chronic Kidney Disease
    Epidemiology Collaboration (CKD-EPI) equation; see Section 9.2 of the protocol)
    7. Hyperkalemia at Screening (defined by 2 local serum K+ values of >5.0 mEq/L
    each obtained from a separate venipuncture, e.g., one in each arm) while receiving ACEi, ARB, ARNi, and/or MRA,
    OR
    Normokalemia at Screening (serum K+ 4.0–5.0 mEq/L) with a history of hyperkalemia documented by a usual care serum K+ measurement >5.0 mEq/L while on RAASi treatment in the 12 months prior to Screening with a subsequent dose decrease or discontinuation of one or more RAASi medications
    8. Females of child-bearing potential must be non-lactating, must have a negative
    pregnancy test at Screening, and must agree to continue using contraception (see Section 9.8 of the protocol) throughout the study and for 4 weeks after study completion
    9. Hospitalization for HF or equivalent (e.g., urgent emergency room or outpatient visit for worsening HF during which the patient received intravenous medications for the treatment of HF) within last 12 months
    1. El sujeto proporciona el consentimiento informado por escrito antes de su participación en el estudio.
    2. 18 o más años de edad.
    3. Antecedentes de IC de clase II-IV según la New York Heart Association (NYHA).
    4. Fracción de eyección del ventrículo izquierdo <40 %, medida por cualquier ecocardiograma, ventriculogammagrafía, o método de tomografía computarizada en los últimos 12 meses (sin medición posterior de la fracción de eyección ≥40 % durante este intervalo).
    5. Recepción de cualquier dosis de betabloqueante (BB) para el tratamiento de la IC o que no pueden tolerar el BB (motivo documentado).
    6. Tasa de filtración glomerular estimada (TFGe) ≥30 ml/min/1,73 m2 en la selección (en función de un único cálculo del laboratorio local utilizando la ecuación de la Colaboración en epidemiología de la enfermedad renal crónica (Chronic Kidney Disease Epidemiology Collaboration, CKD-EPI); consulte la Sección 9.2 del protocolo).
    7. Hiperpotasemia en la selección (definida por 2 valores séricos locales de K+ de >5,0 mEq/l obtenidos cada uno de una venopunción separada, p. ej., una en cada brazo) mientras recibían iECA, ARA, iRAN o ARM,
    O
    Normopotasemia en la selección (suero K+ 4,0–5,0 mEq/l) con antecedentes de hiperpotasemia documentada por una medición de K+ en suero según la atención habitual >5,0 mEq/l mientras esté recibiendo el tratamiento con un iSRAA en los 12 meses anteriores a la selección, con un descenso o una interrupción posteriores de la dosis de uno o varios de los medicamentos iSRAA.
    8. Las mujeres en edad fértil no deben estar en periodo de lactancia, deben tener una prueba de embarazo negativa en la selección y deben aceptar continuar utilizando un método anticonceptivo (consulte la Sección 9.8 del protocolo) a lo largo de todo el estudio y durante 4 semanas después de la finalización del estudio.
    9. Hospitalización por IC o equivalente (p. ej., visita a urgencias o ambulatoria por empeoramiento de la IC en las que el paciente haya recibido medicamentos intravenosos para el tratamiento de la IC) en los últimos 12 meses.
    E.4Principal exclusion criteria
    1.Current acute decompensated HF. Subjects with a discharge from a hospitalization for acute decompensation of HF at least 4 weeks before Screening
    may be included
    2. Symptomatic hypotension or systolic blood pressure <90 mmHg
    3. Significant primary aortic or mitral valvular heart disease (except mitral
    regurgitation due to left ventricular dilatation)
    4. Heart transplantation or planned heart transplantation (i.e., currently on a heart transplant list) during the study period
    5. Diagnosis of peripartum or chemotherapy-induced cardiomyopathy or acute
    myocarditis in the previous 12 months
    6. Implantation of a cardiac resynchronization therapy device in the previous
    4 weeks
    7. Restrictive, constrictive, hypertrophic, or obstructive cardiomyopathy
    8. Untreated ventricular arrhythmia with syncope in the previous 4 weeks
    9. History of, or current diagnosis of, a severe swallowing disorder, moderate-to-severe gastroparesis, or major gastrointestinal (GI) surgery (e.g., bariatric surgery or large bowel resection)
    10. A major CV event within 4 weeks prior to Screening, including acute myocardial infarction, stroke (or transient ischemic attack), a life-threatening atrial or ventricular arrhythmia, or resuscitated cardiac arrest.
    11. Brain natriuretic peptide (BNP) <125 pcg/mL or N-terminal pro b-type brain
    natriuretic peptide (NT-proBNP) of <500 pcg/mL
    12. Liver enzymes (alanine aminotransferase, aspartate aminotransferase) >5 times upper limit of normal at Screening based on the local laboratory
    13. Diagnosis or treatment of a malignancy in the past 2 years, excluding
    non-melanoma skin cancer and carcinoma in situ of the cervix, or a condition
    highly likely to transform into a malignancy during the study
    14. Presence of any condition (e.g., drug/alcohol abuse; acute illness), in the opinion of the Investigator, that places the subject at undue risk, or prevents complete participation in the trial procedures, or potentially jeopardizes the quality of the study data
    15. Use of any investigational product for an unapproved indication within 1 month prior to Screening or currently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
    16. Known hypersensitivity to patiromer (RLY5016) or its components
    17. Prior use of commercial patiromer or previous participation in a study assessing patiromer
    18. Subjects currently being treated with or having taken any one of the following medications in the 7 days prior to Screening: sodium or calcium polystyrene sulfonate or sodium zirconium cyclosilicate
    19. An employee of Relypsa, Vifor Pharma, investigational site or the contract
    research organization (CRO)
    1. IC descompensada aguda actual. Los sujetos con un alta de una hospitalización por descompensación aguda de la IC al menos 4 semanas antes de la selección pueden ser incluidos.
    2. Hipotensión sintomática o presión arterial sistólica <90 mmHg.
    3. Cardiopatía de la válvula mitral o aórtica primaria significativa (excepto insuficiencia mitral debido a dilatación del ventrículo izquierdo).
    4. Trasplante de corazón o trasplante de corazón programado (es decir, está actualmente en una lista de trasplante de corazón) durante el periodo del estudio.
    5. Diagnóstico de periparto, miocardiopatía inducida por quimioterapia o miocarditis aguda en los 12 meses anteriores.
    6. Implantación de un dispositivo de tratamiento de resincronización cardíaca en las 4 semanas anteriores.
    7. Miocardiopatía restrictiva, constrictiva, hipertrófica u obstructiva.
    8. Arritmia ventricular sin tratar con síncope en las 4 semanas anteriores.
    9. Antecedente o diagnóstico actual de un trastorno grave de la deglución, gastroparesia de moderada a grave, o cirugía gastrointestinal (GI) mayor (p. ej., cirugía bariátrica o resección del intestino grueso).
    10. Un episodio CV grave en las 4 semanas anteriores a la selección, entre ellos infarto agudo de miocardio, accidente cerebrovascular (o accidente isquémico transitorio), arritmia auricular o ventricular potencialmente mortal, o parada cardíaca con reanimación.
    11. Péptido natriurético cerebral (PNC) <125 pcg/ml o pro-péptido natriurético cerebral tipo b terminal N (NT-proBNP) de <500 pcg/ml.
    12. Enzimas hepáticas (alanina aminotransferasa, aspartato aminotransferasa) >5 veces el límite superior de la normalidad en la selección según el laboratorio local.
    13. Diagnóstico o tratamiento de una neoplasia maligna en los últimos 2 años, excepto cáncer de piel no melanoma y carcinoma in situ del cuello uterino, o una afección que con gran probabilidad se transforme en una neoplasia maligna durante el estudio.
    14. Presencia de cualquier afección (p. ej., abuso de alcohol/drogas; enfermedad aguda) que, en opinión del investigador, ponga al sujeto ante un riesgo indebido, o impida que complete su participación en los procedimientos del ensayo, o que potencialmente ponga en peligro la calidad de los datos del estudio.
    15. Uso de cualquier producto en investigación para una indicación no aprobada en el plazo de 1 mes antes de la selección o estar actualmente inscrito en cualquier otro tipo de investigación médica que se considere médica o científicamente incompatible con este estudio.
    16. Hipersensibilidad conocida a patirómero (RLY5016) o a sus componentes.
    17. Uso previo de patirómero comercial o participación previa en un estudio de evaluación de patirómero.
    18. Sujetos que estén siendo tratados actualmente o que hayan tomado uno de los siguientes medicamentos en los 7 días anteriores a la selección: sulfonato sódico de poliestireno, sulfonato cálcico de poliestireno o ciclosilicato de sodio y zirconio.
    19. Un empleado de Relypsa, Vifor Pharma, del centro de investigación o de la organización de investigación por contrato (OIC).
    E.5 End points
    E.5.1Primary end point(s)
    Time to first occurrence of CV death or CV hospitalization (or equivalent in outpatient clinic)
    Tiempo hasta la primera aparición de muerte CV o de hospitalizaciones CV (o su equivalente en clínica ambulatoria).
    E.5.1.1Timepoint(s) of evaluation of this end point
    See endpoint description.
    Ver criterio de valoración .
    E.5.2Secondary end point(s)
    •Proportion of subjects on ≥50% of guideline-recommended target dose of ACEi,
    ARB, or ARNi and ≥50% of guideline-recommended target dose of MRA at the
    End of Study (EoS) Visit
    • Total HF hospitalizations (or equivalent in outpatient clinic)
    • Patient reported outcome: Kansas City Cardiomyopathy Questionnaire (KCCQ)
    - Proporción de sujetos con ≥50 % de la dosis objetivo recomendada de las directrices de iECA, ARA o iRAN y ≥50 % de la dosis objetivo recomendada por las directrices de ARM en la visita de fin del estudio (FdE).
    - Total de hospitalizaciones por IC (o su equivalente en clínica ambulatoria).
    - Resultado notificado por el paciente: Cuestionario sobre miocardiopatías de Kansas City (Kansas City Cardiomyopathy Questionnaire, KCCQ).
    E.5.2.1Timepoint(s) of evaluation of this end point
    See endpoint description.
    Ver criterio de valoración .
    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) 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
    Simple ciego durante fase previa y doble ciego durante fase de tratamiento
    Single blind during Run-in phase and double blind during treatment phase
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA156
    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
    Argentina
    Brazil
    Bulgaria
    Czech Republic
    Denmark
    France
    Georgia
    Germany
    Israel
    Italy
    Mexico
    Netherlands
    Poland
    Russian Federation
    Serbia
    Spain
    Sweden
    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 study will continue until the required number of composite endpoint events have occurred.
    El estudio continuará hasta se haya producido el número requerido de acontecimientos del criterio de valoración compuesto.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 1194
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1194
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Illiterate or blinded patients.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state101
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 794
    F.4.2.2In the whole clinical trial 2388
    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.
    Ninguno
    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 Decision2019-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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