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:2015-001903-30
    Sponsor's Protocol Code Number:FHM-1-2015
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-05-13
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-001903-30
    A.3Full title of the trial
    Effect of tolvaptan on RBF and GFR in ADPKD
    Effekten af tolvaptan på RBF og GFR ved polycystisk nyresygdom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of tolvaptan on renal blood flow and glomerular filtration in patients with polycystic kidney disease
    Effekten af tolvaptan på nyrernes gennemblødning og filtrationsevne i patienter med cyste nuresygdom
    A.3.2Name or abbreviated title of the trial where available
    Tolvaptan and RPF in ADPKD
    Tolvaptan og RPF ved ADPKD
    A.4.1Sponsor's protocol code numberFHM-1-2015
    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 SponsorDepartment of Medical Research
    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 supportDepartment of Medical Research
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Medical Research
    B.5.2Functional name of contact pointFrank Mose
    B.5.3 Address:
    B.5.3.1Street AddressLægaardvej 12
    B.5.3.2Town/ cityHolstebro
    B.5.3.3Post code7500
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4528531257
    B.5.6E-mailfrchri@rm.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.2.1.1.1Trade name Samsca
    D.2.1.1.2Name of the Marketing Authorisation holderOtzuka
    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 Chewable 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 INNTolvaptan
    D.3.9.1CAS number 150683-30-0
    D.3.9.3Other descriptive nameTOLVAPTAN
    D.3.9.4EV Substance CodeSUB22755
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult dominant polycystic kidney disease (ADPKD)
    Polycystsisk nyresygdom
    E.1.1.1Medical condition in easily understood language
    Adult dominant polycystic kidney disease (ADPKD)
    Polycystsisk nyresygdom
    E.1.1.2Therapeutic area Body processes [G] - Physical Phenomena [G01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036046
    E.1.2Term Polycystic kidney, autosomal dominant
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this trial is to ivestige if tolvatans improve renal blood flow in ADPKD
    Formålet er at måle akutte effekter af tolvaptatan på den renale hæmodynamik hos patienter med ADPKD.
    E.2.2Secondary objectives of the trial
    The purpose of this trial is to ivestige if tolvatans improve renal blood flow in ADPKD
    Formålet er at måle akutte effekter af tolvaptatan på den renale hæmodynamik (RPF, GFR, FF og RVR), blodtrykket (cBP, bBP) samt flere vasoaktive hormoner (PRC, p-Ang-II, p-Aldo, p.AVP) hos patienter med ADPKD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age > 18 years
    Diagnosis with ADPKD
    Informed consent
    Contraception for fertile women
    • Alder >18 år

    • Patienter med diagnosen ADKPD (Ravine–kriterier), diagnosticeret ved genetisk testning for PKD1 (>85%) og PKD2 mutationer, eller UL-defineret (9-10):

    1. Patienter uden familiær ADKPD anamnese, skal have mere end 10 cyster i hver nyre, andre årsager til ekstra- eller renale cyster skal være udelukket.

    2. Patienter med familiær ADKPD anamnese:

     18-39 år og have mindst 3 cyster uni- eller bilateralt

     40-59 år og have mindst 2 cyster eller flere cyster i hver nyre
     >60 år og have mindst 4 cyster i hver nyre

    • Nyrefunktion svarende til kronisk nyresygdom stadium 1-3 (eGFR> 30 mL/min/1,73 m2)
    • Underskrevet samtykke
    • Fertile kvinder skal anvende sikker antikonception i hele forsøgsperioden, og i en periode efterfølgende, der svarer til 5 gange plasma halveringstiden, dvs mindst 2 døgn. (sikker antikonception defineres som: p-piller, spiral, depotinjektion af gestagen, subdermal implantation, hormonal vaginalring samt transdermal depotplaster)
    E.4Principal exclusion criteria
    • Renal transplantation
    • Operation in the kidnety
    • Diabetes mellitus
    • Neoplastic conditions
    • Pregnancy, nursing
    • Unwillingness to participate
    • eGFR > 30
    • Intolerans towrds tolvaptan
    • Alkohol or medical abuse,
    • BP >>170/110 blodtryk despite regulation
    • Tidligere nyretransplantation
    • Operation på nyrerne
    • Diabetes mellitus
    • Aktuelle neoplastiske lidelser
    • Graviditet, mindre end 6 måneder efter fødsel eller amning
    • Manglende ønske om at deltage
    • eGFR > 30
    • Intolerans overfor eller uacceptable bivirkninger af tolvaptan
    • Alkoholmisbrug, dvs. >14 genstande/uge for kvinder og > 21 genstande/uge for mænd
    • Medicin- eller stofmisbrug
    • Uacceptabelt højt dvs. >170/110 blodtryk på trods af regulering antihypertesiv medicin
    • Uacceptable bivirkninger den antihypertensive medicin, der gives som baggrundsmedicin i projektperioden.
    E.5 End points
    E.5.1Primary end point(s)
    RPF
    RPF
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of trial
    Aflsutning
    E.5.2Secondary end point(s)
    GFR, RVR, FF
    Brachial and central BP
    PRC, p-Ang-II, p-Aldo, p-AVP
    Urinflow, u-Na, u-K, u-albumin, u-creatinin, u-osmolalitet, u-AQP-2 in 24 hour urine
    GFR, RVR, FF
    Brakialt og centralt blodtryk
    PRC, p-Ang-II, p-Aldo, p-AVP
    Urinflow, u-Na, u-K, u-albumin, u-creatinin, u-osmolalitet, u-AQP-2 i døgnurin
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    Afslutning
    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 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 Yes
    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 last visit of the last sunsbject
    Sidste forsøgspersones sidste besøg
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state30
    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)
    Usual treatment
    Normal behandling
    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 Decision2015-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-12-13
    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-Wed Apr 24 18:45:15 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA