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    Summary
    EudraCT Number:2022-002681-32
    Sponsor's Protocol Code Number:20018510
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2022-002681-32
    A.3Full title of the trial
    Lumasiran in hyperoxalaemic patients on haemodialysis
    Lumasiran für Hämodialysepatienten mit Hyperoxalämie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to find out if the drug Lumasiran can be used for patients on haemodialysis with high oxalate levels in the blood.
    Studie, um herauszufinden, ob das Medikament Lumasiran bei Hämodialysepatienten mit hohem Oxalatgehalt im Blut eingesetzt werden kann.
    A.4.1Sponsor's protocol code number20018510
    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 SponsorCharité Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportAlynylam Pharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité Universitätsmedizin Berlin
    B.5.2Functional name of contact pointGerlineke Hawkins-van der Cingel
    B.5.3 Address:
    B.5.3.1Street AddressCharité - Universitätsmedizin Berlin Campus Mitte AG Knauf Hessischestr. 3-4
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number49304507530067
    B.5.5Fax number49304507514928
    B.5.6E-mailgerlineke.hawkins-van-der-cingel@charite.de
    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 Oxlumo (Lumasiran)
    D.2.1.1.2Name of the Marketing Authorisation holderAlnylam Netherlands B.V.
    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 nameOxlumo
    D.3.2Product code EMEA/H/C/005040
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLumasiran
    D.3.9.3Other descriptive nameLumasiran sodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number189
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hyperoxalaemia in patients with End Stage Kidney Disease.
    Hyperoxalämie bei Patienten mit Nierenerkrankung im Endstadium.
    E.1.1.1Medical condition in easily understood language
    People who have kidneys which no longer work often have high oxalate levels in their blood, partly because oxalate usually leaves the body via the kidneys in the urine.
    Menschen, deren Nieren nicht mehr funktionieren, haben oft hohe Oxalatwerte im Blut, auch weil Oxalat den Körper normalerweise über die Nieren mit dem Urin verlässt.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    To assess if this medication can successfully lower plasma oxalate levels in patients with End Stage Kidney Disease on haemodialysis.
    Es soll untersucht werden, ob dieses Medikament den Oxalatspiegel im Plasma von Patienten mit Nierenerkrankungen im Endstadium, die an einer Hämodialyse teilnehmen, erfolgreich senken kann.
    E.2.2Secondary objectives of the trial
    To assess:
    - safety and tolerability of this medication in this population
    - exploratory biomarkers for safety and cardiovascular health
    - any change in echocardiogram findings at the start and end of the trial
    zu bewerten:
    - Sicherheit und Verträglichkeit dieses Medikaments in dieser Bevölkerungsgruppe
    - explorative Biomarker für Sicherheit und kardiovaskuläre Gesundheit
    - Veränderungen der Echokardiogramm-Befunde zu Beginn und am Ende der Studie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Both male and female patients
    • Aged between ≥18 and ≤80 years old
    • Women of child-bearing age to consent to either abstinence or the use of contraception during the study period
    • Patients must have capacity to give written, informed consent to participate in the study prior to commencing the study. They must be fully aware of the aims, nature, planned interventions and potential risks of participating in the study
    • Established and stable on haemodialysis for at least 2 months
    • Thrice weekly haemodialysis
    • In possession of permanent dialysis access – either arterio-venous fistula (AVF) or graft (AVG) or permanent dialysis catheter/tunnelled haemodialysis line (THL)
    • Any cause of ESKD except previously diagnosed primary hyperoxaluria.
    • Baseline serum oxalate level of >20 µmol/L
    • No recent (within last 2 months) significant changes to regular medications or diet
     Sowohl männliche also auch weibliche Patienten
     Alter zwischen ≥18 und ≤80 Jahren
     Frauen im gebärfähigen Alter, die der Abstinenz oder der Verwendung von Verhütungsmitteln während des Studienzeitraums zustimmen
     Die Patienten müssen in der Lage sein, vor Beginn der Studie eine schriftliche, informierte Einwilligung zur Teilnahme an der Studie zu geben. Sie müssen über die Ziele, die Art, die geplanten Eingriffe und die potenziellen Risiken der Teilnahme an der Studie vollständig informiert sein.
     Seit mindestens 3 Monaten etablierte und stabile Hämodialysebehandlung
     Dreimal wöchentlich Hämodialysebehandlung
     Im Besitz eines permanenten Dialysezugangs - entweder arterio-venöse Fistel(shunt) (AVF) oder Transplantat/Graft (AVG) oder permanenter Dialysekatheter/getunnelte Hämodialyseleitung (THL)
     Jede Ursache einer ESKD außer einer zuvor diagnostizierten primären Hyperoxalurie.
     Ausgangswert der Serum-Oxalat-Spiegel >20µmol/L
     Keine kürzlich (innerhalb von 2 Monaten) vorgenommenen wesentlichen Änderungen der regelmäßigen Medikation oder der Ernährung
    E.4Principal exclusion criteria
    • Age less than 18 or over 80 years old
    • Known diagnosis of PH1, 2 or 3; or a pathological mutation documented to cause primary hyperoxaluria
    • Established on haemodialysis for less than 3 months or on peritoneal dialysis or combined haemodialysis and peritoneal dialysis
    • Temporary or poorly functioning haemodialysis access
    • Pregnancy, planning pregnancy or currently breast feeding
    • Co-morbidity of an enteric disorder such as Inflammatory Bowel Disease (IBD), short gut syndrome, or a malabsorptive disorder.
    • Decompensated Liver failure
    • Intercurrent active infection and/or antibiotic treatment
    • Currently on Vitamin C treatment with a daily dose of more than 250mg
    • Terminal illness and/or life expectancy of less than 1 year
    • Currently relapsed or uncontrolled and symptomatic psychiatric disorder preventing compliance with the study
    • Patients who could be coerced due to dependency on the sponsor, the investigator or the trial sites
    • Deranged LFTs: If alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is more than twice the upper limit of normal, or if the total bilirubin is above 1.5x the upper limit of normal. If the patient is diagnosed with Gilbert’s syndrome then a total bilirubin up to twice the upper limit of normal is acceptable
    • Deranged clotting: Patients with an International normalised ratio (INR) of more than 2.0 will be excluded unless they are oral therapeutic anticoagulants in which case only an INR >3.5 will be unacceptable.
    • A history of multiple medical drug allergies or a history of allergy to an oligonucleotide or GalNAc
    • Currently taking any other investigational agent
     Alter ≤18 oder ≥80 Jahren
     Bekannte Diagnose von PH1, 2 oder 3; oder eine pathologische Mutation, die nachweislich eine primäre Hyperoxalurie verursacht
     Seit weniger als 3 Monaten an der Hämodialyse oder Peritonealdialyse oder kombinierte Hämodialyse und Peritonealdialyse etabliert.
     Vorübergehender oder schlecht funktionierender Hämodialysezugang
     Schwangerschaft, geplante Schwangerschaft oder Stillzeit
     Komorbidität einer Darmerkrankung wie entzündliche Darmerkrankung (IBD), Kurzdarmsyndrom, malabsorptive Störung
     Dekompensiertes Leberversagen
     Derzeitige aktive Infektion und/oder Antibiotikabehandlung
     Derzeitige Vitamin-C-Behandlung mit einer Tagesdosis von mehr als 250 mg
     Unheilbare Krankheit und/oder Lebenserwartung von weniger als 1 Jahr
     Derzeit rezidivierende oder unkontrollierte und symptomatische psychiatrische Störungen, die die Einhaltung der Studie verhindern.
     Patienten, die aufgrund ihrer Abhängigkeit vom Sponsor, dem Prüfer/Investigator oder den Prüfzentren gezwungen werden könnten.
     Leberfunktionstests: Wenn die Alanin-Aminotransferase (ALT) oder Aspartat-Aminotransferase (AST) mehr als das Doppelte des oberen Grenzwerts beträgt oder wenn das Gesamtbilirubin über dem 1,5-fachen des oberen Grenzwerts liegt. Wird bei dem Patienten das Gilbert-Syndrom diagnostiziert, so ist ein Gesamtbilirubinwert bis zum Zweifachen des oberen Grenzwerts akzeptabel.
     Patienten mit einem INR-Wert (International normalized ratio) von mehr als 2,0 werden ausgeschlossen, wenn sie keine gerinnungshemmenden Medikamente einnehmen. Patienten, die orale Antikoagulanzien [z. B. Warfarin] einnehmen, werden nur ausgeschlossen, wenn der INR-Wert über 3,5 liegt.
     Mehrere Arztneimittelallergien oder eine Allergie gegen ein Oligonukleotid oder GalNAc
     Derzeitige Einnahme eines anderen Prüfpräparats
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    The primary endpoint is the percentage/relative change in pre-dialysis plasma oxalate levels from baseline to month 6, using an average of measurements from month 3 through month 6. The treatment group will be compared with the placebo group.
    Primäres Ziel:

    Der primäre Endpunkt ist die prozentuale/relative Veränderung des Oxalatspiegels im Plasma vor der Dialyse vom Ausgangswert bis zum sechsten Monat, wobei der Durchschnitt der Messungen von Monat 3 bis Monat 6 verwendet wird. Die Behandlungsgruppe wird mit der Placebogruppe verglichen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monthly for the 6 months after administration of the first dose of the IMP/placebo.
    Monatlich für 6 Monaten nach Verabreichung der ersten Dosis des Prüfpräparats/Placebo.
    E.5.2Secondary end point(s)
    Secondary Objectives/Endpoints:
    The secondary objectives include an assessment of safety and tolerability. The endpoints are:
    - Absolute change in pre-dialysis plasma oxalate levels from baseline to month 6, comparing the treatment group with the placebo group.

    - Tolerability will be assessed using an adapted FACIT Instrument validated questionnaire (severity of side effects rated on scale between 0 and 4). Again the answers of the two study arms will be compared.

    Additionally we will assess the following exploratory outcomes:

    - Overall mortality rate from day 1 until the end of the trial compared between the two groups.

    - Cardiovascular morbidity event rate from month 0 until the end of the trial compared between the two groups.

    - Changes in following exploratory biomarkers: full blood count, liver function tests including albumin, urea and electrolytes, HCO3-, inflammatory markers (C-Reactive Protein, CK, LDH, white blood cell count), bone profile, (calcium/phosphate), Troponin and NT-pro-BNP. Laboratory shift tables for these parameters will be produced on a monthly basis for both placebo and treatment groups from month 0 until month 6. This will allow comparison between the two groups and help identify if there are any potentially harmful trends.

    - Change in transthoracic echocardiogram findings between baseline and month 6. Speckle echocardiogram techniques will be used to primarily assess left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS), both of these parameters are recorded as a percentage. An abnormal GLS is defined as <15%. We will report the percentage change in LVEF and/or GLS for both groups. A baseline abnormal LVEF is defined as <55%, and an abnormal GLS as <15%. We will record whether patients have an improvement of ≥5% in LVEF and/or an improvement on ≥2% in GLS.

    Die sekundären Ziele umfassen eine Bewertung der Sicherheit und Verträglichkeit. Die Endpunkte sind:
    - Absolute Veränderung des Oxalatspiegels im Plasma vor der Dialyse vom Ausgangswert bis zum sechsten Monat, wobei die Behandlungsgruppe mit der Placebogruppe verglichen wird.

    - Die Verträglichkeit wird anhand eines angepassten, validierten Fragebogens des FACIT-Instruments bewertet (Schweregrad der Nebenwirkungen auf einer Skala von 0 bis 4). Auch hier werden die Antworten der beiden Studiengruppen miteinander verglichen.

    Zusätzlich werden wir die folgenden explorativen Endpunkte bewerten:
    - Gesamtsterblichkeitsrate vom ersten Tag bis zum Ende der Studie im Vergleich zwischen den beiden Gruppen.

    - Rate der kardiovaskulären Morbiditätsereignisse von Monat 0 bis zum Ende der Studie im Vergleich zwischen den beiden Gruppen.

    - Veränderungen bei folgenden explorativen Biomarkern: vollständiges Blutbild, Leberfunktionstests einschließlich Albumin, Harnstoff und Elektrolyte, HCO3-, Entzündungsmarker (C-reaktives Protein, CK, LDH, Anzahl der weißen Blutkörperchen), Knochenprofil (Kalzium/Phosphat), Troponin und NT-pro-BNP. Für diese Parameter werden für die Placebo- und die Behandlungsgruppe von Monat 0 bis Monat 6 monatliche Laborverschiebungstabellen erstellt, die einen Vergleich zwischen den beiden Gruppen ermöglichen und helfen, potenziell schädliche Trends zu erkennen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Exploratory blood biomarkers will be taken every month prior to the dose of the study drug
    - Mortality and morbidity data will be collected at the end of the study.
    - Patients will be interviewed monthly (and spontaeously at the participants' request) for tolerability
    - An echocardiogram will be performed at the start (before the administration of the study drug) and end of the trial
    - Jeden Monat vor der Verabreichung des Studienmedikaments werden Biomarker aus dem Blut entnommen, die der Untersuchung dienen.
    - Am Ende der Studie werden Daten zur Mortalität und Morbidität erhoben.
    - Die Patienten werden monatlich (und spontan auf Wunsch der Teilnehmer) zur Verträglichkeit befragt.
    - Ein Echokardiogramm wird zu Beginn (vor der Einnahme des Studienmedikaments) und am Ende der Studie 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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 end of the trial will be the last visit of the last subject undergoing the trial. This visit will either be the echocardiogram or the last interview and blood test.
    Das Ende der Studie ist der letzte Besuch des letzten Probanden, der an der Studie teilnimmt. Dieser Termin ist entweder das Echokardiogramm oder die letzte Befragung und Blutuntersuchung.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state60
    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)
    All the patients included will be dialysis patients, their usual haemodialysis care will continue post trial.
    Alle eingeschlossenen Patienten sind Dialysepatienten, deren übliche Hämodialyseversorgung nach der Studie fortgesetzt wird.
    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 Decision2023-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-08-16
    P. End of Trial
    P.End of Trial StatusOngoing
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