Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-000222-35
    Sponsor's Protocol Code Number:2017-000222-35
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-07-12
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-000222-35
    A.3Full title of the trial
    Effect of etelcalcetide on cardiac hypertrophy in hemodialysis patients – a randomized controlled trial
    Effekt von Etelcalcetide auf die kardiale Hypertrophie in Hämodialysepatienten - eine randomizierte, kontrollierte Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of the drug etelcalcetide on heart muscle enlargement in hemodialysis patients - a randomized, controlled trial
    Effekt von dem Medikament Etelcalcetide auf die Herzmuskelvergrößerung in Hämodialysepatienten - eine randomizierte, kontrollierte Studie
    A.4.1Sponsor's protocol code number2017-000222-35
    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 SponsorMedical University of Vienna
    B.1.3.4CountryAustria
    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 supportAmgen Europe B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen Europe B.V. BREDA
    B.5.2Functional name of contact pointAmgen Europe B.V.
    B.5.3 Address:
    B.5.3.1Street AddressMinervum 7061
    B.5.3.2Town/ cityBreda
    B.5.3.3Post code4817ZK
    B.5.3.4CountryNetherlands
    B.5.5Fax number0031076-5732001
    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 Parsabiv
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen GmbH
    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 nameEtelcalcetide
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETELCALCETIDE
    D.3.9.3Other descriptive nameAMG 416
    D.3.9.4EV Substance CodeSUB178987
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 Etalpha
    D.2.1.1.2Name of the Marketing Authorisation holderLeo Pharma
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameAlfacalcidol
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALFACALCIDOL
    D.3.9.3Other descriptive nameALFACALCIDOL
    D.3.9.4EV Substance CodeSUB05312MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.2.1.1.1Trade name Parsabiv
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen GmbH
    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 nameEtelcalcetide
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETELCALCETIDE
    D.3.9.3Other descriptive nameAMG 416
    D.3.9.4EV Substance CodeSUB178987
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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
    Secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis therapy.
    Sekundärer Hyperparathyreoidismus in erwachsenen Patientinnen und Patienten mit chronischer Niereninsuffizienz unter Hämodialysetherapie.
    E.1.1.1Medical condition in easily understood language
    Bone mineral disorder which occurs in patients with chronic kidney disease and require renal replacement therapy in the form of hemodialysis.
    Knochenstoffwechselerkrankung welche bei Patientinnen und Patienten mit chronischer Niereninsuffizienz auftritt, welche ein Nierenersatzverfahren in Form einer Hämodialyse benötigen.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In this randomized, multicenter trial we will study the effect of etecalcitide versus alfacalcidol on left ventricular hypertrophy (LVH) and fibrosis in hemodialysis patients with secondary hyperparathyroidism (sHPT). Etecalcitide is a calcimimetic drug that has been approved for the treatment of sHPT in dialysis patients.
    FGF23 increases the development of LVH in these patients and is further associated with progression to end-stage renal disease, cardiac events and all-cause mortality. In animal models a blockade of FGF23 ameliorates the pathologic effect on left ventricular mass and function. Calcimimetic therapy has been shown to reduce systemic FGF23 levels while vitamin D therapy increases it. However, there is limited data on the clinical relevance of therapeutic modification of FGF23 levels in humans.
    We hypothesize that treatment with etelcalcetide ameliorates pathological changes in cardiac structure in dialysis patients with sHPT by suppression of systemic FGF23 levels.
    In dieser randomisierten multizentrischen Studie werden die Effekte von Etelcalcetide versus Alfacalcidol auf die Linksventrikelhypertrophie (LVH) und Fibrose in Hämodialysepatienten mit sekundärem Hyperparathyreoidismus (sHPT) untersucht. Etelcalcetide ist ein kalzimimetisches Medikament, welches zugelassen is für die Therapie des sHPT.
    FGF23 verstärkt die Entwicklung von LVH in diesen Patienten und ist assoziiert mit der Zunahme der Niereninsuffizienz, akuten kardialen Ereignissen und Mortalität. Im Tiermodel zeigte eine Blockade von FGF23 einen lindernden Effekt auf die Linksventrikelmasse und Funktion. Kalzimimetika führen zu einer Reduktion und Vitamin D zu einer Erhöhung von FGF23 im Blut. Bisher ist noch wenig über die klinische Relevanz der therapeutischen Modifikation von FGF23 in Menschen bekannt.
    Wir vermuten, dass eine Senkung von FGF23 durch die Therapie mit Etelcalcetide die pathologischen Veränderungen der Herzmuskelstruktur in Dialysepatienten mit sHPT vermindert.
    E.2.2Secondary objectives of the trial
    Cardiac structure apart from left ventricular hypertrophy, i.e. Left atrial diameter, cardiac fibrosis, wall motion abnormalities and left ventricular function compared in the etelcalcetide vs. alfacalcidol group.
    Laboratory parameters: electrolytes, PTH, BNP, troponin T (pre and postdialysis), FGF23, soluble klotho levels.
    Analysis of the renin-angiotensin-aldosterone system (“RAAS fingerprint”)
    Herzstruktur neben der Linksventrikelhypertrophie, i.e. linksatrialer Durchmesser, Herzfibrose, Wandbewegungsstörungen, Linksventrikelfunktion- Vergleich zwischen den beiden Therapiegruppen- Etelcalcetide und Alfacalcidol.
    Laborparameter: electrolytes, PTH, BNP, Troponin T (vor und nach Dialyse), FGF23, soluble klotho.
    Analyse vom Renin-Angiotensin-Aldosteronsystem ("RAAS fingerprint")
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • ≥ 18 years of age
    • Treatment with maintenance hemodialysis 3 times a week for ≥ 3 months and ≤3
    years
    • sekundary hyperparathyroidism defined by
    o Parathyroid hormone levels obtained from the central laboratory of ≥300 pg/mL and no prior treatment with a calcimimetic drug, or
    o patients under treatment with cinacalcet who will be eligible following a washout phase of 4 weeks
    • serum calcium levels obtained from the central laboratory of ≥ 2.08 mmol/L
    • Signs of left ventricular hypertrophy (increased myocardial thickness in the left ventricle, increased intraventricular septum thickness) +/- signs of cardiac fibrosis in cardiac imaging
    (Echocardiography)
    • State of optimal fluid composition i.e. reaching the individual dry weight as measured
    with the help of a Body Composition Monitor. Pulmonary edema will be excluded with the help of lung ultrasound (lung comet tails).
    • No substantial dose change of calcium supplements, phosphate binders, dialysate calcium 4 weeks before screening
    • ≥ 18 Jahre alt
    • Chronische Dialysetherapie 3 Mal wöchentlich für ≥ 3 Monate und ≤ 3 Jahre
    • sekundärer Hyperparathyreoidismus definiert als
    o Parathormonwerte aus dem Serum ≥300 pg/mL ohne vorangehende Therapie mit einem kalzimimetischen Medikament, oder
    o Patienten unter Therapie mit Cinacalcet, die nach einer Auswaschphase von 4 Wochen eingeschlossen werden
    • Serum Kalzium von ≥ 2.08 mmol/L
    • Zeichen von Linksventrikelhypertrophie (= erhöhte Herzmuskeldicke im linken Ventrikel, erhöhte intraventrikuläre Septumdicke) +/- Zeichen von Herzfibrose in kardialer Bildgebung (Echokardiographie)
    • Optimale Körperwasserzusammensetzung i.e. Erreichen des Trockengewichtes gemessen mit Body Composition Monitor (BCM). Lungenödem wird mithilfe von Lungenultraschall (lung comet tails) ausgeschlossen.
    • Keine wesentlichen Dosisveränderungen von Kalziumsubstitution, Phosphatbindern, Dialysatkalzium 4 Wochen vor dem Screening.
    E.4Principal exclusion criteria
    • Unstable medical condition based on medical history, physical examination, and routine laboratory tests, or judged unstable in the investigator’s opinion
    • Significantly impaired left ventricular systolic function or significant, hemodynamically effective heart valve defects
    • History of any illness, which in the investigator’s opinion, might confound the results of the study or pose additional risk
    • Anticipated parathyreoidectomy within 6 months after randomization
    • Scheduled date for kidney transplant from a living donor
    • Uncontrolled hyperphosphatemia
    • Subject is currently enrolled in or has not yet completed at least 30 days since ending
    other investigational device or drug trial(s), or subject is receiving other
    investigational agent(s)
    • Subject has known sensitivity or intolerance to any of the products to be
    administered for the purpose of this study
    • Subject has any kind of disorder that compromises the ability of the subject to give
    written informed consent and/or to comply with the study procedures
    • Subject is pregnant, or is of child-bearing potential and not using adequate contraceptive precautions
    • Contraindications for MRI (implanted MR-Unsafe – objects that are significantly
    ferromagnetic and pose a clear and direct threat to persons and equipment within
    the magnet room)
    • Overhydration as measured in BCM or visualized in lung ultrasound
    • Instabiler Gesundheitszustand basierend auf der medizinischen Vorgeschichte, der körperlichen Untersuchung, Laboruntersuchungen bzw. vom Untersucher als instabil eingestuft
    • Signifikant verminderte Linksventrikelfunktion oder signifikant, hämodynamisch wirksame Herzklappenpathologien
    • Vorgeschichte von Krankheiten, die nach Auffassung des Untersuchers die Resultate der Studie beeinflussen könnten oder ein zusätzliches Risiko darstellen könnten
    • Geplante Parathyreoidektomie innerhalb von 6 Monaten nach Einschluss
    • Geplante Lebendnierentransplantation
    • Unkontrollierbare Hyperphosphatämie
    • Der Patient ist derzeit in einer anderen Studie eingeschlossen in welcher ein anderes Medikamet verabreicht wird oder Medizinprodukt verwendet wird- bzw. die Teilnahme des Patienten an anderen solchen Studien ist noch nicht mindestens 30 Tage her
    • Es besteht eine vorbekannte Allergie oder Unverträglichkeit gegenüber den in der Studie verabreichten Stoffen
    • Der Patient hat eine Erkrankung welche es ihm unmöglich macht seine schriftliche Zustimmung zur Teilnahme abzugeben sowie an den Studienmaßnahmen teilzunehmen
    • Die Patientin ist schwanger oder in gebärfähigem Alter ohne adäquater Verhütungsmethode
    • Kontraindikation gegen die Durchführung eines MRTs (MRT-untaugliche Implantate/Geräte welche ferromagnetisch sind sowie eine klare und direkte Gefahr für die betroffene Person bzw. die Utensilien im MRT-Raum darstellen)
    • Überwässerung, gemessen im BCM oder sichtbar im Lungenultraschall
    E.5 End points
    E.5.1Primary end point(s)
    In this trial we will determine the influence of calcimimetic therapy versus vitamin D therapy on left ventricular hypertrophy in hemodialysis patients with secondary hyperparathyroidism (HPT): We will perform a trial testing etecalcitide treatment vs alfacalcidol on top of conventional HPT therapy (phosphate binders, calcium substituation) for 12 months. Etecalcitide or alfacalcidol will be administered intravenously three times per week following chronic hemodialysis treatment. The primary end point will be a change in left ventricular mass index that will be assessed using cardiac magnetic resonance imaging at baseline and after 12 months of treatment.
    In dieser Studie wird der Einfluss von kalzimimetischer Therapie versus Vitamin D Therapie auf die Linksventrikelhypertrophie in Hämodialysepatienten mit sekundärem Hyperparathyreoidismus (HPT) untersucht: wir werden eine Studie durchführen in welcher das Medikament Etelcalcetide gegen Alfacalcidol zusätzlich zu konventioneller HPT-Therapie (Phosphatbinder, Calciumsubstitution) für 12 Monate verabreicht wird. Etelcalcetide oder Alfacalcidol werden 3 Mal wöchentlich i.v. nach der Dialysebehandlung verabreicht. Der Primäre Endpunkt ist eine Veränderung des Linksventrikulären Massenindex, welcher mithilfe von Herz-MRT Untersuchungen, welche vor sowie nach 12-monatiger Therapie durchgeführt werden.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cardiac MRI performed at baseline as well as after 12 months of study.
    HerzMRT vor Beginn der Therapie sowie nach 12-monatiger Therapie
    E.5.2Secondary end point(s)
    As secondary end points we will measure changes in left atrial diameter, cardiac fibrosis, wall motion abnormalities and left ventricular function (in cardiac MRI as well as strain echocardiography) as well as changes in electrolytes, PTH, BNP, troponin T (pre and post dialysis), serum FGF 23 and soluble Klotho levels.
    Additionally, the renin-angiotensin-aldosterone system (RAAS) metabolites will be analyzed with the help of mass spectrometry (“RAAS fingerprint”).
    Als sekundäre Endpunkte werden wir Unterschiede im linksatrialen Durchmesser, der kardialen Fibrose, der Herzwandbewegungsstörungen, der Linksventrikelfunktion (im Herz-MRT sowie Strain-Herzechokardiographie) sowie der Elektrolyte, des PTH, des BNP, des Troponin T (vor und nach Dialyse) und der Laborwerte FGF23 und soluble klotho messen.
    Zusätzlich werden Metabolite des Renin-Angiotensin-Aldosteronsystems (RAAS) untersucht mithilfe einer Massenspektroskopie ("RAAS Fingerprint").
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cardiac MRI and echocardiography with strain will be performed at baseline as well as after 12 months of therapy.
    Laboratory tests will be performed multiple times in clearly defined intervalls.
    RAAS fingerprint will be performed at baseline as well as after 12 months of therapy.
    HerzMRTs und Herzechokardiographie-Untersuchungen mit Strain vor Beginn der Therapie sowie nach 12-monatiger Therapie.
    Laboruntersuchungen werden in genau definierten Zeitintervallen mehrfach durchgeführt.
    RAAS fingerprints werden vor Beginn der Therapie sowie nach 12-monatiger Therapiephase durchgeführt.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.3Single blind Yes
    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) Yes
    E.8.2.2Placebo No
    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 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 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 trial is completed if 62 patients have received the treatment (etelcalcetide or alfacalcidol) for 12 months and completed all the requested procedures (screening procedures, cMRI at baseline and after the treatment phase, strain echocardiography at baseline and after the treatment phase, multiple laboratory measurements) or are lost to follow up or dropped out of the study.
    Die Studie ist beendet wenn 62 Patienten die Therapie (Etelcalcetide oder Alfacalcidol) 12 Monate lang verabreicht bekommen haben und alle notwendigen Untersuchungen durchgeführt haben (Screening Untersuchungen, cMRT zu Beginn sowie nach 12 Monaten Therapie, Strain Echokardiographie zu Beginn sowie nach 12 Monaten Therapie, mehrfache Laboruntersuchungen) oder die Studie frühzeitig verlassen/abgebrochen haben.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 31
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    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 state62
    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
    Keine
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-23
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 00:27:36 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA