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    Summary
    EudraCT Number:2022-000740-29
    Sponsor's Protocol Code Number:270389-030122
    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:2022-03-04
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2022-000740-29
    A.3Full title of the trial
    Sodium glucose cotransporter 2 inhibitors or Mineralocorticoid receptor antagonists for the treatment of Albuminuric Chronic Kidney Disease - A randomized controlled trial
    Sodium-glucose Cotransporter-2 eller Mineralocorticoid-receptor-antagonister til behandling af Albuminurisk Kronisk Nyresygdom - Et randomiseret kontrolleret studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A comparison of two drugs for treating patients with Chronic Kidney Disease and protein in the urine
    En sammenligning af to lægemidler til behandling af patienter med Kronisk Nyresygdom og protein i urinen
    A.3.2Name or abbreviated title of the trial where available
    SMACKD
    SMACKD
    A.4.1Sponsor's protocol code number270389-030122
    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 Renal Medicine, Aarhus University Hospital
    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 supportHenrik Birn
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Renal Medicine, Aarhus University Hospital
    B.5.2Functional name of contact pointFrederik Husum Mårup
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Boulevard 35
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.6E-mailfremaa@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.2.1.2Country 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 nameFinerenone
    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 INNFinerenone
    D.3.9.1CAS number 1050477-31-0
    D.3.9.4EV Substance CodeSUB183743
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 2
    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.2.1.2Country 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 nameDapagliflozine
    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 INNDapagliflozin
    D.3.9.1CAS number 461432-26-8
    D.3.9.4EV Substance CodeSUB31650
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Kidney Disease with albuminuria
    Kronisk Nyresygdom med albuminuri
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney Disease with protein in the urine
    Kronisk Nyresygdom med protein i urinen
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10001580
    E.1.2Term Albuminuria
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this trial is to investigate and compare the effect of Finerenone and Dapagliflozine on albuminuria, both separately and in combination, added to treatment with ACE-I/ARB in patients with non-diabetic chronic kidney disease and albuminuria.
    Formålet med dette studie er at undersøge og sammenligne effekten af Finerenon og Dapagliflozin på albuminuri, både hver for sig og i komination, i tillæg til behandling med ACE-I/ARB hos patienter med non-diabetisk kronisk kronisk nyresygdom og albuminuri.
    E.2.2Secondary objectives of the trial
    The study will further investigate the safety and tolerability of separate and combined treatment including the effect on renal blood flow, oxygenation and glomerular filtration rate, P-potassium, blood pressure and the possible mechanism behind a renoprotective effect.
    Studiet vil videre undersøge sikkerhed og tolerabilitet af separat og kombineret behandling inklusiv effekten på nyrens blodgennemstrømning, oxygenering og glomerulær filtrationsrate samt P-kalium, blodtryk og de mulige mekanismer bag en renoprotektiv effekt.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18-80
    2. eGFR 25-45
    3. Urine albumine creatinine ratio 150-2000 mg/g
    4. Current treatment with maximal RAAS-blockade (ACE-I/ARB) or maximal tolerated dose as judged by the investigator
    5. Current stable treatment with ACE-I/ARB (i.e. dose unchanged for the past 4 weeks)
    1- Alder 18-80
    2. eGFR 25-45
    3. Urin albumin kreatinin ratio 150-2000 mg/g
    4. Aktuel RAAS-blokade (ACE-I/ARB) i maksdosis jf. pro.medicin eller maksimalt tålte dosis ud fra investigators vurdering
    5. Stabil behandling med RAAS-blokade i form af uændret ACE-I/ARB-dosis seneste 4 uger
    E.4Principal exclusion criteria
    1. Diabetes
    2. ADPKD
    3. Active vasculitis (current or planned treatment) with renal involvement
    4. Systolic BP > 160mmHg or diastolic BP > 100mmHg
    5. P-potassium >4.5mmol/L
    1. Diabetes
    2. ADPKD
    3. Aktiv vaskulit (nuværende eller planlagt behandling) affektion af nyrer
    4. Systolisk blodtryk > 160 eller diastolisk blodtryk >100mmHg
    5. P-kalium >4.5mmol/L
    E.5 End points
    E.5.1Primary end point(s)
    The change in albuminuria from baseline to after combined treatment with Dapagliflozine og Finerenone
    Ændringer i albuminuri fra baseline til efter kombineret behandling med Dapagliflozin og Finerenon
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and after 8 weeks
    Baseline og efter 8 uger
    E.5.2Secondary end point(s)
    1. Change in GFR measured using 99mTecnetium-DTPA
    2. Change in renal bloodflow and oxygenation measured using BOLD-MR R2*
    3. P-potassium
    4. Change in blood pressure measured at home and using BpTRU
    5. Changes in above measured at 4 weeks (Dapagliflozine or Finerenone) vs. baseline and 8 weeks (combined treatment) vs. 4 weeks (single drug)
    1. Ændringer GFR målt ved 99mTecnetium-DTPA
    2. Ændringer i renalt blodflow og iltforbrug målt ved BOLD-MR R2*
    3. P-kalium
    4. Ændringer i blodtryk målt ved hjemmemåling og BPtru
    5. Ændringer i ovenstående vurderet ved 4 ugers monoterapi (Dapagliflozin eller Finerenon) vs. baseline og 8 ugers dobbeltbehandling vs. 4 ugers monoterapi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 4 and 8 weeks
    Baseline, 4 og 8 uger
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days
    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: 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 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 state20
    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)
    Renal outpatient Clinic, Aarhus University Hospital
    Nyremedicinsk klinik, Aarhus Universitetshospital
    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 Decision2022-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-29
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