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    Summary
    EudraCT Number:2014-001973-15
    Sponsor's Protocol Code Number:SAFA-2-2014
    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:2014-06-27
    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 number2014-001973-15
    A.3Full title of the trial
    Renal Handling of Water and Sodium in Autosomal Dominant Polycystic Kidney Disease.
    The effects of tolvaptan on renal handling of water and sodium , vasoactive hormones and central hemodynamics during baseline conditions and after inhibition of the nitric oxide system in patients with autosomal dominant polycystic kidney disease
    Nyrernes behandling af vand og natrium ved cystenyresygdom.
    Effekten af tolvaptan på nyrernes behandling af vand og natrium, vasoaktive hormoner og central hæmodynamik under basale omstændigheder og efter hæmning af nitrogenoxid- systemet hos
    patienter med autosomal dominant arvelig cystenyresygdom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effcts of tolvaptan on renal handling of water and salt, hormones in the blood at the circulation, during blocking of the nitric oxide (NO) system in patients with autosomal dominant polycystic kidney disease
    Effekten af tolvaptan på nyrernes behandling af vand og salt, hormoner i blodet samt kredsløbet ved samtidig blokering af nitrogenoxid( NO)- systemet hos patienter med autosomal dominant arvelig cystenyresygdom
    A.3.2Name or abbreviated title of the trial where available
    TOPO
    A.4.1Sponsor's protocol code numberSAFA-2-2014
    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 SponsorUniversity Clinic in Nephrology and Hypertension, Department 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 supportPublic and private funding
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHolstebro Hospital
    B.5.2Functional name of contact pointDepartment of Medical Research
    B.5.3 Address:
    B.5.3.1Street AddressLaegaardvej 12
    B.5.3.2Town/ cityHolstebro
    B.5.3.3Post code7500
    B.5.3.4CountryDenmark
    B.5.4Telephone number004578436589
    B.5.5Fax number004578436582
    B.5.6E-mailJeppe.Rosenbaek@randers.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 holderOtsuka Pharmaceutival Europe LTD Hunton House Highbridge Business Park Oxford Road Uxbridge Middlese
    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 nameTolvaptan
    D.3.2Product code C03XA01
    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 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 number30
    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
    Hyponatreamia
    SIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion)
    Overhydration
    Autosomal dominant polycystic kidney disease
    Hyponatriæmi
    SIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion)
    Overhydrering
    Autosomal dominant arvelig polycystisk nyresygdom
    E.1.1.1Medical condition in easily understood language
    Decreased salt in blood
    Overhydration
    Lavt saltindhold i blodet
    Overhydrering
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10021038
    E.1.2Term Hyponatremia
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10040626
    E.1.2Term SIADH
    E.1.2System Organ Class 100000004860
    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 the effects of tolvaptan on the nitroc oxide system.
    At undersøge effekten af tolvaptan på nitrogenoxid-systemet.
    E.2.2Secondary objectives of the trial
    The purpose of the present study is to measure the effects of tolvaptan and octreotide on (1) renal function (GFR, u-AQP2, u-ENACγ, CH2O, u-cAMP, FENa), (2) vasoactive hormones (p-AVP, p-Aldo, PRC, Ang.II, p-ANP, endot-I and p-BNP), and (3) central haemodynamics (central blood pressure, pulse wave velocity and augmentation index), under basal conditions and during inhibition of NO in ADPKD patients.
    Formålet med dette studie er at måle samt sammenligne effekten af tolvaptan på (1) nyrefunktionen (GFR, u- AQP2, CH20, u-cAMP, FENa, u-ENACγ, ), (2) vasoaktive hormoner (p-AVP, p-Aldo,PRC, p-ang.II, p-ANP, p-BNP), (3) central hæmodynamik ( cBT, PWV og AI) og (4) renal clearance af nitrit og nitrat( u-nitrit, u-nitrat, p-nitrit, p-nitrat) dels basalt, dels efter hæmning af nitrogenoxid syntesen hos patienter med ADPKD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Caucasian men and women
    2) Age between 18-65 years
    3) ADPKD, diagnosed by genetic testing of PKD1 (>85%) or PKD2 mutations, or by ultrasonography:
    a) patients with negative family history for ADKPD and more than 10 cysts in each kidney and no extrarenal or renal findings that suggest causes to cyst formation.
    b) patients with positive family history for ADPKD:
    • 15-39 yr of age and at least 3 or more unilateral or bilateral.
    • 40-59 yr of age and 2 or more cysts in each kidney.
    • 60 yr of age and at least 4 cysts in each kidney.
    4) Kidney function corresponding to CKD stages 1-3(eGFR> 30 mL/min/1,73 m2)
    5) BMI between 18.5 and 30 kg/m2.
    1) Kaukasisike mænd og kvinder
    2) Alder mellem 18-65 år
    3) Patienter med dignosen ADKPD, diagnostiseret ved genetisk testning for PKD1 (>85%) og PKD2 mutationer, eller UL-defineret :
    a. patienter uden familiær ADKPD anamese, skal have mere end 10 cyster i hver nyre, andre årsager til ekstra- eller renale cyster skal være udelukket.
    b. Patienter med familiær ADKPD anamese:
    15-39 år og have mindst 3 cyster uni eller bilateralt
    40-39 år og have mindst 2 cyster eller flere cyster i hver nyre
    60 år og have mindst 4 cyster i hver nyre
    4) Nyrefunktion svarende til kronisk nyresygdom stadium 1-3 (eGFR> 30 mL/min/1,73 m2)
    5) BMI mellem 18.5 and 30 kg/m2.
    E.4Principal exclusion criteria
    1) Clinical signs of diseases in the heart, lungs, endocrine organs, brain or neoplastic disease, 2) clinically significant abnormalities in blood or urine sample at the inclusion 3) previous cerebrovascular insults, 4) previous clinical evidence for aneurysm 5) Alcohol or drug abuse, 6) smoking, 7) pregnancy or breastfeeding, 8) clinically significant changes in the electrocardiogram, 9) medication except antihypertensive agents and oral contraceptives.
    1) Betydende kliniske tegn på hjertesygdom, sygdomme i lunger, lever, endokrine organer eller hjernen samt neoplastiske lidelser eller tidligere intrakranielle aneurismer.
    2) klinisk betydende abnorme fund i urin-eller blodprøver ved inklusionen, 4) tidligere cerebrovascular accident (CVA) eller klinisk evidens for aneurisme.
    5) alkoholmisbrug, dvs. >14 genstande/uge for kvinder og > 21 genstande/uge for mænd eller stofmisbrug, 6) rygning, 7) graviditet eller amning, 8) klinisk betydende kliniske forandringer i elektrokardiogram, 9) fast medicin, fraset kontraceptiv behandling for kvinder samt antihypertensiv behandling.
    E.5 End points
    E.5.1Primary end point(s)
    CH2O ( free water clearance)
    CH2O ( frit vands clearance)
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study.
    Ved forsøgets afslutning.
    E.5.2Secondary end point(s)
    1) Renal function (GFR, u-AQP2, u-ENACγ, CH2O, u-cAMP, FENa), 2) vasoactive hormones (p-AVP, p-Aldo, PRC, Ang.II, p-ANP, endot-I and p-BNP), 3) central haemodynamics (central blood pressure, pulse wave velocity and augmentation index) and 4) renal clearance of nitrite and nitrate (u-nitrite, u-nitrate, p-nitrite, p-nitrate).
    1) Nyrefunktionen (GFR, u- AQP2, CH20, u-cAMP, FENa, u-ENACγ, ), 2) vasoaktive hormoner (p-AVP, p-Aldo,PRC, p-ang.II, p-ANP, p-BNP), 3) central hæmodynamik ( cBT, PWV og AI) og
    4) renal clearance af nitrite og nitrat (u-nitrit, u-nitrat, p-nitrit, p-nitrat).
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study.
    Forsøgets 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.8.4.1Number of sites anticipated in Member State concerned1
    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 subject.
    Det sidste besøg af den sidste forsøgsperson.
    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
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 25
    F.1.3Elderly (>=65 years) No
    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 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 state25
    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 Decision2014-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-14
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