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    Summary
    EudraCT Number:2020-001595-15
    Sponsor's Protocol Code Number:270389-010520
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-24
    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 number2020-001595-15
    A.3Full title of the trial
    The Measures to Optimize RAAS-blockade in Patients with Hyperkalemia and Chronic Kidney Disease
    Undersøgelse af den nyrebeskyttende effekt ved optimeret blokade af Renin-Angiotensin-Aldosteron-Systemet gennem samtidig brug af kaliumbinder (Patiromer) hos patienter med kronisk nyresygdom og albuminuri
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Measures to slow the progression of chronic kidney disease in patients with protein in the urine and elevated potassium in the blood
    Et videnskabeligt forsøg med personer med kronisk nyresvigt og protein i urinen
    A.3.2Name or abbreviated title of the trial where available
    MorphCKD
    MorphCKD
    A.4.1Sponsor's protocol code number270389-010520
    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 SponsorHenrik Birn
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVifor Fresenius Medical Care Renal Pharma AG
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportGraduate School of Health Sciences, Aarhus University
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHenrik Birn
    B.5.2Functional name of contact pointDept. of Renal Medicine, AUH
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Boulevard 35
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.6E-mailhb@biomed.au.dk
    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.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameSpironolactone
    D.3.4Pharmaceutical form Tablet
    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 INNSPIRONOLACTONE
    D.3.9.1CAS number 52-01-7
    D.3.9.4EV Substance CodeSUB10631MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 50
    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.IMP: 2
    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
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Oral powder in sachet
    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
    D.3.9.1CAS number 1415477-49-4
    D.3.9.3Other descriptive namePATIROMER SORBITEX CALCIUM
    D.3.9.4EV Substance CodeSUB181624
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number8.4 to 25.2
    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.IMP: 3
    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.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameLosartan
    D.3.4Pharmaceutical form Coated tablet
    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 INNLOSARTAN
    D.3.9.1CAS number 114798-26-4
    D.3.9.4EV Substance CodeSUB08593MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 100
    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
    Chronic kidney disease with albuminuria
    Kronisk nyresygdom med albuminuri
    E.1.1.1Medical condition in easily understood language
    Chronic kidney disease with protein in the urine
    Kronisk nyresygdom med æggehvidestof i urinen
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10020647
    E.1.2Term Hyperkalemia
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10001580
    E.1.2Term Albuminuria
    E.1.2System Organ Class 10038359 - Renal and urinary 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 investigate if concomitant treatment with Patiromer will lead to a greater reduction in albuminuria when compared to treatment without Patiromer in patients with chronic kidney disease, albuminuria and a history of hyperkalemia.
    This is based on the notion, that concomitant treatment with the potassium binder Patiromer will allow for more intensive treatment with inhibitors of the renin-angiotensin-aldosterone system (Losartan and/or Spironolactone) leading to reduction in albuminuria being an established surrogate marker of the progression of chronic kidney disease.
    At undersøge om samtidig behandling med Patiromer fører til en større reduktion i graden af albuminuri sammenlignet med behandling uden Patiromer hos patienter med kronisk nyresvigt, albuminuri og tendens til hyperkaliæmi.

    Dette er baseret på antagelsen om, at samtidig behandling med kaliumbinderen Patiromer vil tillade mere intensiv behandling med hæmmere af renin-angiotensin-aldosteron-systemet (Losartan og/eller Spironolacton) førende til en reduktion i graden af albuminuri, som er en surrogat-markør for progression af kronisk nyresygdom.
    E.2.2Secondary objectives of the trial
    The study will further investigate, if concomitant treatment with Patiromer and a more intensive treatment with inhibitors of the renin-angiotensin-aldosterone system (Losartan and/or Spironolactone) in patients with chronic kidney disease, albuminuria and a history of hyperkalemia will lead to changes in blood pressure control, kidney function, plasma-potassium, intake of potentially healthy, potasium rich foods such as fruit and vegetables, quality of life as well as a number of markers of cardiovascular health including left ventricular ejection fraction, pulse wave velocity, and cardiovascular biomarkers, when compared to patients not treated with Patiromer. Furthermore, the study will assess the safety of concomitant treatment with Patiromer and a more intensive treatment with inhibitors of the renin-angiotensin-aldosterone system (losartan and/or spironolactone) by comparing the incidence of severe hyperkalemia and acute renal failure.
    Studiet vil videre undersøge, om samtidig behandling med Patiromer og mere intensiv behandling med hæmmere af renin-angiotensin-aldosteron-systemet (Losartan og/eller Spironolacton) hos patienter med kronisk nyresvigt, albuminuri og tendens til hyperkaliæmi vil føre til ændringer i blodtrykskontrol, nyrefunktion, plasma-kalium, indtag af sunde, kaliumholdige fødevarer som frugt og grønt, livskvalitet og en række markører for kardiovaskulær sygdom, inklusiv venstre-ventrikel-ejection-fraction, pulsbølgehastighed og kardiovaskulære biomarkører, sammenlignet med patienter der ikke behandles med Patiromer.
    Envidere vil studiet undersøge sikkerheden af samtidig behandling med Patiromer og samtidig mere intensiv behandling med hæmmere af renin-angiotensin-aldosteron-systemet (Losartan og/eller Spironolacton) with at sammenligne incidensen af svær hyperkaliæmi og akut nyresvigt.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18-80 years
    2. eGFR 25-60 mL/min/1.73 m2
    3. Latest P-potassium > 4.5 mmol/L or b) P-kalium > 4.5 mmol/L at least twice within the last 24 months
    4. Urine albumin creatinine ratio > 500 mg/g or 200mg/g and diabetes
    1. Alder 18-80 år
    2. eGFR mellem 25-60 mL/min/1.73 m2
    3. a) Seneste P-kalium > 4.5 mmol/L eller b) P-kalium > 4.5 mmol/L mindst 2 gange i løbet af de seneste 24 måneder
    4. Urin albumin/kreatinin-ratio > 500 mg/g eller 200mg/g og diabetes
    E.4Principal exclusion criteria
    1. Intolerance or allergic to Losartan, Spironolactone or Patiromer
    2. Previous renal transplant recipient or active on the waiting ling
    3. End stage renal disease (defined as the need for dialysis or renal transplantation)
    4. Any condition that currently or through the duration of the study would require specific immunosuppressive therapy
    5. Pregnancy
    6. Regular use of Trimethoprim and/or NSAIDs
    7. Disseminated cancer disease
    8. Addisons disease
    9. History of heart failure defined as Ejection Fraction (EF) < 40% or currently receiving treatment at a heart failure clinic or similar
    10. Porphyria
    11. Severe constipation requiring daily and chronic use of laxatives and/or previous recurrent ileus (> 1 incident in the past 10 years without curative treatment
    12. Fructose intolerance
    13. Galactose intolerance
    14. A history of severe liver insufficiency (Child–Pugh score B-C)
    15. SGLT2-inhibitor treatment initated ≤ 30 days prior to inclusion
    1. Intolerance eller allergi over for både ACE-I og Losartan eller Spironolacton eller patiromer
    2. Tidligere nyretransplantation eller aktiv på venteliste til nyretransplantation
    3. ESRD (defineret som behov for dialyse eller nyretransplantation)
    4. Enhver lidelse der aktuelt eller forventeligt i løbet af studiet vil kræve specifik immundæmpende behandling
    5. Graviditet eller manglende mulighed for at bruge sikker antikonception, dvs. spiral eller hormonel
    (p-piller, implantat, transdermal depotplaster, vaginalring eller depotinjektion)
    6. Regelmæssigt behov for brug af trimethoprim og/eller NSAID-præparater
    7. Dissemineret cancer-sygdom
    8. Addisons Sygdom
    9. Hjertesvigt defineret som kendt Ejection Fraction (EF) < 40% eller pågående behandlingsforløb i hjertesvigtsklinik eller tilsvarende.
    10. Porfyri.
    11. Svær opstipation med behov for kronisk og fast laksantiabehandling og/eller tidligere og recidiverende ileus-tilstand (> 1 tilfælde de seneste 10 år , som ikke er kurativt behandlet)
    12. Fruktoseintolerans
    13. Galactoseintolerans
    14. Svær leverinsufficiens (Child–Pugh score B-C)
    15. Behandling med SGLT2-hæmmer opstartet ≤ 30 dage forud for inklusion
    E.5 End points
    E.5.1Primary end point(s)
    The difference in the change in albuminuria (urinary albumin/creatinine ratio) between patients assigned to treatment with Patiromer and patients not assigned to Patiromer as evaluated by the average of 2 morning spot urine samples.
    Forskellen mellem ændringen i graden af albuminuri (Urin-albumin/kreatinin ratio) vurderet ud fra gennemsnittet af 2 morgen spot-urin målinger hos patienter randomiseret til behandling med Patiromer sammenlignet med patienter radomiseret til behandling uden Patiromer.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization to end of study (52 weeks)
    Fra randomisering til studiets afslutning (52 uger)
    E.5.2Secondary end point(s)
    1. The difference in amount of albuminuria between the two groups evaluated by a spot urine sample and a 24h urine collection at the end of treatment.
    2. The difference in the change of albuminuria between the two groups evaluated by a 24h urine collection from randomization to the end of trial
    3. The difference in the extent of treatment with inhibitors of the renin-angiotensin-aldosterone-system (Losartan and/or Spironolactone) between the two groups at the end of trial.
    4. The difference in the change of the extent of treatment with inhibitors of the renin-angiotensin-aldosterone-system (Losartan and/or Spironolactone) between the two groups from randomization to the end of trial.
    5. The difference in renal function (eGFR and urine-creatinine-clearance) between the two groups and the end of treatment.
    6. The difference in the change in renal function (eGFR and urine-creatinine-clearance) between the two groups from randomization to the end of treatment.
    7. The difference in blood pressure (ambulatory and 24h) between the two groups at the end of treatment.
    8. The difference in the change in blood pressure (ambulatory and 24h) between the two groups from randomization to the end of treatment.
    9. The difference in pulse-wave-velocity between the two groups at the end of treatment.
    10. The difference in the change in pulse-wave-velocity between the two groups from randomization to the end of treatment.
    11. The difference in left-ventricular function (ejection fraction) between the two groups at the end of treatment.
    12. The difference in the change in left-ventricular function (ejection fraction) between the two groups from randomization to the end of treatment.
    13. The difference in cardiac biomarkers between the two groups at the end of treatment.
    14. The difference in the change in cardiac biomarkers between the two groups from randomization to the end of treatment.
    15. The difference in P-potassium between the two groups at the end of treatment.
    16. The difference in the number of episodes with severe hyperkalemia (P-potassium > 6.2mmol/L) between the two groups from randomization to the end of treatment.
    17. The difference in the number of episodes with acute renal failure between the two groups from randomization to the end of treatment.
    18. The difference in the amount of fruit and vegetables in the diet between the two groups at the end of treatment.
    19. The difference in the change in amount of fruit and vegetables in the diet between the two groups from randomization to the end of treatment.
    20. The difference in the change the quality of life between the two groups from randomization to the end of treatment.
    1. Forskel i graden af albuminuri mellem de to interventionsgrupper vurderet ud fra hhv. spoturinmåling (jfr. ovenfor) og en døgnurin-opsamling ved behandlingens afslutning.
    2. Forskel i ændringen i albuminuri mellem de to interventionsgrupper vurderet ud fra en døgnurin-opsamling fra randomisering til behandlingens afslutning.
    3. Forskel i omfanget af behandling med hæmmere af renin-angiotensin-aldosteron-systemet (losartan og/eller spironolakton) mellem de to interventionsgrupper ved behandlingens afslutning.
    4. Forskel i ændringen i omfanget af behandling med hæmmere af renin-angiotensin-aldosteron-systemet(Losartan og/eller Spironolakton) mellem de to interventionsgrupper fra randomisering til behandlingens afslutning.
    5. Forskel i nyrefunktion (eGFR hhv. urin-kreatinin clearance) mellem de to interventionsgrupper ved behandlingens afslutning.
    6. Forskel i ændringen i nyrefunktion (eGFR hhv. urin-kreatinin clearance) mellem de to interventionsgrupper fra randomisering til behandlingens afslutning.
    7. Forskel i blodtryk (konsulationsblodtryk hhv. døgnblodtryk) mellem de to interventionsgrupper ved behandlingens afslutning.
    8. Forskel i ændringen i blodtryk (konsulationsblodtryk hhv. døgnblodtryk) mellem de to interventionsgrupper fra randomisering til behandlingens afslutning.
    9. Forskel i pulsbølgehastighed mellem de to interventionsgrupper ved behandlingens afslutning.
    10. Forskel i ændringen i pulsbølgehastighed mellem de to interventionsgrupper fra randomisering til behandlingens afslutning.
    11. Forskel i venstre ventrikelfunktion (ejection fraction) mellem de to interventionsgrupper ved behandlingens afslutning.
    12. Forskel i ændringen venstre ventrikelfunktion (ejection fraction) mellem de to interventionsgrupper fra randomisering til behandlingens afslutning.
    13. Forskel i kardielle biomarkører mellem de to interventionsgrupper ved behandlingens afslutning.
    14. Forskel i ændringen kardielle biomarkører mellem de to interventionsgrupper fra randomisering til behandlingens afslutning.
    15. Forskel i P-kalium mellem de to interventionsgrupper ved behandlingens afslutning.
    16. Forskel i antallet af episoder med svær hyperkaliæmi (P-kalium >6.2 mmol/L) mellem de to interventionsgrupper fra randomisering til behandlingens afslutning.
    17. Forskel i antallet af episoder med akut nyresvigt mellem de to interventionsgrupper fra randomisering til behandlingens afslutning.
    18. Forskel i indtagelsen af frugt og grønt mellem de to interventionsgrupper ved behandlingens afslutning.
    19. Forskel i ændringen indtagelsen af frugt og grønt antallet mellem de to interventionsgrupper fra randomisering til behandlingens afslutning.
    20. Forskel i ændringen i livskvalitet mellem de to interventionsgrupper fra randromisering til behandlingens afslutning.
    E.5.2.1Timepoint(s) of evaluation of this end point
    : At the end of treatment (52 weeks after randomization)
    2, 4, 6, 8, 10, 12, 14, 16, 17, 19, 20: From randomization to the end of treatment (52 weeks)
    1, 3, 5, 7, 9, 11, 13, 15, 18: Ved studiets afslutning (52 uger efter randomisering)
    2, 4, 6, 8, 10, 12, 14, 16, 17, 19, 20: Fra randomisering til studiets afslutning (52 uger)

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    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
    Standard klinisk praksis (uden Patiromer)
    Standard clinical care (without Patiromer)
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state140
    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
    Ingen
    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 Decision2020-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-23
    P. End of Trial
    P.End of Trial StatusCompleted
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