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    Summary
    EudraCT Number:2022-000596-40
    Sponsor's Protocol Code Number:112930
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-16
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-000596-40
    A.3Full title of the trial
    Effect of dapaglifozin on serum magnesium in HNF1β patients with renal hypomagnesemia
    Het effect van dapaglifozine op het serum magnesium in HNF1β-patiënten met een renale hypomagnesiëmie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of dapagliflozin on blood magnesium levels in patients with low magnesium due to HNF1beta-associated kidney disease
    Het effect van dapagliflozine op het magnesiumgehalte bij patiënten met een laag magnesium door HNF1beta-geassocieerde nierziekte
    A.3.2Name or abbreviated title of the trial where available
    DAPA-MAG
    DAPA-MAG
    A.4.1Sponsor's protocol code number112930
    A.5.4Other Identifiers
    Name:PaNaMaIDNumber:112930
    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 SponsorRadboudumc
    B.1.3.4CountryNetherlands
    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 supportDutch Kidney Foundation
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportAstraZeneca
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudumc
    B.5.2Functional name of contact pointDepartment of Nephrology
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein zuid 8
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310243614761
    B.5.5Fax number00310243635125
    B.5.6E-mailsecretariaat.nier@radboudumc.nl
    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 Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Renal hypomagnesemia in ADTKD-HNF1β patients
    Renale hypomagnesiëmie bij ADTKD-HNF1β patiënten
    E.1.1.1Medical condition in easily understood language
    Low magnesium levels in patients with HNF1beta-associated kidney disease
    Laag magnesiumgehalte bij patiënten met een HNF1beta geassocieerde nierziekte
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of SGLT2 inhibition with dapagliflozin 10 mg on serum magnesium in diabetic and non-diabetic ADTKD-HNF1β patients with renal hypomagnesemia.
    Evalueren van het effect van SGLT2-remming met dapagliflozine 10 mg op het serum magnesium bij ADTKD-HNF1β patiënten met een renale hypomagnesiëmie, met en zonder diabetes.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of SGLT2 inhibition with dapagliflozin 10 mg on renal fractional magnesium excretion in diabetic and non-diabetic ADTKD-HNF1β patients with renal hypomagnesemia.

    - To evaluate the effect of SGLT2 inhibition with dapagliflozin 10 mg on symptoms in diabetic and non-diabetic ADTKD-HNF1β patients with renal hypomagnesemia.
    - Evalueren van het effect van SGLT2-remming met dapagliflozin 10 mg op de renale fractionele magnesium excretie bij ADTKD-HNF1β patiënten met een renale hypomagnesiëmie, met en zonder diabetes.

    - Evalueren van het effect van SGLT2-remming met dapagliflozin 10 mg op symptomen bij ADTKD-HNF1β patiënten met een renale hypomagnesiëmie, met en zonder diabetes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Genetically proven ADTKD-HNF1β disease
    - Renal hypomagnesemia (serum magnesium < 0.70 mmol/l)
    - Age 16 – 75 years
    - Informed consent
    - Genetisch bewezen ADTKD-HNF1β
    - Renale hypomagnesiëmie (serum magnesium < 0.70 mmol/l)
    - Leeftijd 16 – 75 jaar
    - Informed consent
    E.4Principal exclusion criteria
    - All other types of diabetes mellitus, including type 1 and type 2 diabetes
    - History of kidney transplantation
    - Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment
    - Previous intolerance for an SGLT2 inhibitor
    - Pregnancy or lactation
    - Use of loop diuretics or thiazide diuretics and inability to discontinue these medications before start of the trial
    - eGFR < 30 ml/min/1,73m2
    - Patients with severe hepatic impairment (Child-Pugh class C).
    - Alle andere types van diabetes mellitus, waaronder diabetes mellitus type 1 en type 2
    - Niertransplantatie in de voorgeschiedenis
    - Behandeling met een SGLT2-remmer in de 4 weken voorafgaand aan de studie
    - Eerdere intolerantie voor een SGLT2-remmer
    - Zwangerschap of het geven van borstvoeding
    - Gebruik van lis- of thiazidediuretica waarbij het niet mogelijk is om deze medicatie te staken voor de start van de studie.
    - eGFR < 30 ml/min/1,73m2
    - Ernstige leverfunctiestoornis (Child-Pugh klasse C)
    E.5 End points
    E.5.1Primary end point(s)
    Change in serum magnesium
    Verandering in serum magnesium
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 4 weeks of treatment
    Na 4 weken behandeling
    E.5.2Secondary end point(s)
    - Renal fractional magnesium excretion
    - Magnesium supplementation requirement
    - Symptoms scored by symptom questionnaire
    - Renale fractionele magnesium excretie
    - Benodigde dosering van magnesiumsuppletie
    - Symptomen gescoord middels een gepersonaliseerde symptomen vragenlijst
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 4 weeks of treatment
    Na 4 weken behandeling
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 concerned3
    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 No
    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
    Laatste visite van laatste deelnemer
    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
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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.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)
    If this trial shows a beneficial effect of dapagliflozin on serum magnesium, patients with diabetes mellitus and/or chronic kidney disease can continue treatment with dapagliflozin, since these patients have a registered indication for treatment with an SGLT2 inhibitor. For the patients without diabetes mellitus and chronic kidney disease, dapagliflozine first has to be registered for the indication 'renal hypomagnesemia' before treatment with dapagliflozin can be continued in these patients.
    Indien deze studie een gunstig effect van dapagliflozine op het serum magnesium laat zien, kunnen patiënten met diabetes mellitus en/of chronische nierschade de behandeling met dapagliflozine continueren aangezien zij een geregistreerde indicatie voor een behandeling met een SGLT2-remmer hebben. Voor de patiënten zonder diabetes en chronische nierschade zal dapagliflozine eerst geregistreerd moeten worden voor de indicatie 'renale hypomagnesiëmie'.
    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 Decision2022-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-10
    P. End of Trial
    P.End of Trial StatusOngoing
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