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    Summary
    EudraCT Number:2013-003585-14
    Sponsor's Protocol Code Number:SNOXH94C301
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-04
    Trial results View 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 number2013-003585-14
    A.3Full title of the trial
    Safety, PK/PD and efficacy of NOX-H94 in dialysis patients with ESA-hyporesponsive anaemia: A randomized, double blind, placebo controlled parallel group study with a single blind cross-over group
    Verträglichkeit, PK/PD und Wirksamkeit von NOX-H94 bei Dialysepatienten mit ESA-hyporesponsiver Anämie: Eine randomisierte, doppelblinde, placebokontrollierte Parallelgruppenstudie mit einer einfachblinden Cross-over Gruppe
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Pharmacology of NOX-H94 in renal dialysis patients with ESA resistant anaemia
    Verträglichkeit, PK/PD und Wirksamkeit von NOX-H94 bei Dialysepatienten mit funktioneller Eisenmangelanämie
    A.3.2Name or abbreviated title of the trial where available
    SNOXH94C301
    A.4.1Sponsor's protocol code numberSNOXH94C301
    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 SponsorNOXXON Pharma AG
    B.1.3.4CountryGermany
    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 supportNOXXON Pharma AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNOXXON Pharma AG
    B.5.2Functional name of contact pointMedical and Scientific Affairs
    B.5.3 Address:
    B.5.3.1Street AddressMax-Dohrn-Strasse 8-10
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10589
    B.5.3.4CountryGermany
    B.5.4Telephone number004930726 247205
    B.5.5Fax number004930726 247201
    B.5.6E-mailclinic@noxxon.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 No
    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 nameNOX-H94 Hepcidin Antagonist
    D.3.2Product code NOX-H94
    D.3.4Pharmaceutical form Solution for 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 INNLexaptepid Pegol
    D.3.9.1CAS number 1322069-19-1
    D.3.9.2Current sponsor codeNOX-H94
    D.3.9.3Other descriptive nameNOX-H94 Hepcidin Antagonist
    D.3.9.4EV Substance CodeSUB33167
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14.6
    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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Erythropoiesis stimulating agents (ESA) hyporesponsive anaemia in renal dialysis patients
    E.1.1.1Medical condition in easily understood language
    Anaemia in renal dialysis patients that does not respond to agents (ESA) that stimulate red cell production
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level SOC
    E.1.2Classification code 10038359
    E.1.2Term Renal and urinary disorders
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level SOC
    E.1.2Classification code 10005329
    E.1.2Term Blood and lymphatic system disorders
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10058123
    E.1.2Term Renal anaemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system 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 assess the safety and tolerability of single and repeated doses of NOX-H94 in dialysis patients
    Beurteilung der Sicherheit und Verträglichkeit nach einmaliger Gabe und bei wiederholter Verabreichung von NOX-H94 bei Dialysepatienten
    E.2.2Secondary objectives of the trial
    • To study the PK with a focus on plasma accumulation and elimination, the PD, and the efficacy of NOX-H94 in dialysis patients with functional iron deficiency
    • To obtain first data on efficacy of NOX-H94 with regard to the response of Hb
    • Untersuchung der PK mit besonderem Augenmerk auf Wirkstoffkumulation im Plasma und Elimination, der PD sowie der Wirksamkeit von NOX-H94 bei Dialysepatienten mit funktionellem Eisenmangel
    • Erhebung erster Daten zur Wirksamkeit von NOX-H94 im Hinblick auf das Ansprechen der Hb-Konzentration
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent
    2. Male or female of non-childbearing potential
    3. Age 18 to 85 years
    4. End stage renal disease treated with maintenance haemodialysis since ≥3 months, 3 times weekly
    5. Anaemia : Hb 7 to 11 g/dL
    6. Functional iron deficiency: Transferrin saturation <30%,
    Ferritin ≥300 ng/mL.
    7. ESA hyporesponsiveness with erythropoietin dose ≥12,000 IU/ week stable for ≥4 weeks
    E.4Principal exclusion criteria
    1. Inability to personally provide written informed consent or to under-stand and collaborate throughout the study.
    2. Inability or unwillingness to comply with study restrictions.
    3. Participation in any clinical research study evaluating an investigational drug or therapy within 30 days from screening visit or prior enrolment in this study.
    4. Pregnancy or lactation.
    5. Treatment with darbepoetin or methoxy-polyethylenglycol-epoetin
    6. Uncontrolled cardiovascular disease, unstable peripheral arterial or cerebrovascular disease, uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg).
    7. Congestive heart failure: New York Heart Association Class III or IV.
    8. Unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty/stents, or coronary artery bypass grafting <3 months prior screening.
    9. Any other medical conditions requiring a change in treatment within 4 weeks prior to screening or making study participation unadvisable (at the discretion of the investigator).
    10. History of clinically relevant haemolysis and/or blood loss.
    11. AST, ALT, or bilirubin ≥2.0 times the upper limit of normal.
    12. Known bone marrow fibrosis.
    13. Treatment with i.v. iron <4 weeks prior to screening or during the screening period or change in erythropoietin dose during last month.
    14. Any acute or chronic infection, viral or bacterial within 4 weeks prior to screening or during the screening period that, according to investigator's judgement, is considered as systemic infection.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of adverse events, either spontaneously reported or resulting from safety and tolerability.
    Inzidenz unerwünschter Ereignisse, entweder spontan berichtet oder anhand der Erhebungen zur Sicherheit und Verträglichkeit festgestellt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety parameters will be evaluated after IMP administration throughout the treatment and follow up periods.
    Parameter zur Erhebung der Sicherheit/Verträglichkeit werden nach Verabreichung des Prüfpräparates während der Behandlungs- und Nachbeobachtungsphase beurteilt.
    E.5.2Secondary end point(s)
    • PK of NOX-H94 after single and repeat i.v. doses of IMP in dialysis patients
    • PD of NOX-H94 after single i.v. dose of NOX H94 evaluated through serum iron concentration changes
    • PD and efficacy of NOX-H94 after repeated doses of NOX-H94 evaluated through changes in serum ferritin, soluble transferrin receptors (sTfR), interleukin-6, reticulocyte haemoglobin content (CHr), mean corpuscular haemoglobin (MCH), Hb and reticulocytes


    • PK von NOX-H94 nach einmaliger und wiederholter i.v. Verabreichung des Prüfpräparates bei Dialysepatienten
    • PD von NOX-H94 nach i.v. Einmalgabe von NOX-H94, beurteilt anhand der Veränderungen der Serum-Eisenkonzentration
    • PD und Wirksamkeit von NOX H94 nach wiederholter Verabreichung von NOX H94, beurteilt anhand der Veränderungen der Serumkonzentrationen von Ferritin, des löslichen Transferrin-Rezeptors (sTFR), von Interleukin-6, des Hämoglobingehalts in den Retikulozyten (CHr), des mittleren Hämoglobingehalts pro Erythrozyt (MCH), des Hb-Werts und der Retikulozytenzahl
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK endpoints assessed at the following timepoints:
    Group 1: Day 8, 9, 10, 12, 15, 22 and 36
    Groups 2/3: Day 1, 3, 8, 15, 22, 29, 36, 43 and 57

    Pharmacodynamics and efficacy endpoints:
    Group 1: Day 1, 2, 8, 9, 10, 12, 15 and 22
    Groups 2/3: Day 1, 8, 15, 22, 29, 36 and 43
    PK Endpunkte werden zu folgenden Zeitpunkten beurteilt:
    Gruppe 1: Tag 8, 9, 10, 12, 15, 22 und 36.
    Gruppe 2/3: Tag 1, 3, 8, 15, 22, 29 36, 43 und 57.

    Pharmakodynamik und Wirksamkeitsendpunkte:
    Gruppe 1: Tag 1, 2, 8, 9, 10, 12, 15 und 22
    Gruppe 2/3: Tag 1, 8, 15, 22, 29, 36 und 43
    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 Yes
    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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Single-blind, cross-over for Group 1 only
    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 trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    LVLS
    Letzter Patient letzer Besuch
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 32
    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
    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 Decision2014-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-16
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