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    Summary
    EudraCT Number:2017-000992-10
    Sponsor's Protocol Code Number:FHM-1-2017
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2017-04-28
    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 number2017-000992-10
    A.3Full title of the trial
    Prednisolone treatment in acute interstitial nephritis
    Prednisolon behandling ved akut interstitiel nefritis – et randomiseret, prospektivt studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prednisolone treatment in acute interstitial nephritis
    Prednisolon behandling ved inflammation i nyrernes bindevæv – et randomiseret, prospektivt studie
    A.3.2Name or abbreviated title of the trial where available
    PRAISE
    PRAISE
    A.4.1Sponsor's protocol code numberFHM-1-2017
    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 SponsorUniversitets klinik for nyresygdomme og Hypertension
    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 supportUniversitets klinik for nyresygdomme og Hypertension
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitets klinik for nyresygdomme og hypertension
    B.5.2Functional name of contact pointHospitalsenheden Vest
    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+4578436580
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Prednisolone
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    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 namePrednisolone
    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.3.9.1CAS number 125-02-0
    D.3.9.3Other descriptive namePREDNISOLONE
    D.3.9.4EV Substance CodeSUB10018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 to 25
    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
    Acute interstitial nephritis
    akut interstitiel nefritis
    E.1.1.1Medical condition in easily understood language
    Acute interstitial nephritis
    Inflammation i nyrenes bindevæv
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10048302
    E.1.2Term Tubulointerstitial nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10000819
    E.1.2Term Acute interstitial nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10022614
    E.1.2Term Interstitial nephritis acute
    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
    To investigate the effect of prednisolone treatment in acute interstitial nephritis.
    Patienter med akut interstitiel nefritis (AIN) debuterer med akut nyresvigt. Der kan være flere ledsagende symptomer. Tilstanden giver risiko for permanet nyrefunktions nedsættelse. Det er omdiskuteret om prednisolon-behandling kan afkorte sygdomsvarigheden og bedre prognosen for nyrefunktionen. Der findes ingen prospektive studier men indikationer fra retrospektive opgørelser.
    Formålet med dette studie er, i et kontrolleret randomiseret design, at undersøge effektiviteten af prednisolon behandling ved AIN.
    E.2.2Secondary objectives of the trial
    as above
    som overfor
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Biopsi proven acute interstitial nephritis (AIN).
    • Clinical suspision of AIN
    • Age of minimum 18 years.
    • one of the two following criteria
    o Creatinine > 120 mmol/l or
    o Creatinine increase of > 30 mmol/l or r 1,5 x creatinine-increase
    • Women with child bearing potential
    • Biopsi-verificeret AIN.
    • Klinisk mistanke om AIN
    • Alder på minimum 18 år.
    • Et af de to følgende kriterier
    o Kreatinin over 120 mol/l eller
    o Kreatinin stigning på > 30 mol/l eller 1,5 x kreatinin-stigning sammenlignet med sidste måling inden AIN. Der skal minimum være 7 dage mellem målingerne
    • Kvinder med graviditets-potentiale, som ikke bruger anti-konceptiva, kan inkluderes da projektmedicinen er veltolereret hos gravide.
    E.4Principal exclusion criteria
    • Not able to give consent.
    • IImmunosuppressive therapy within 3 months
    • Autoimmune disease.
    • Allergy or intolerance towards MP eller prednisolone.
    • Pregnancy or nursing
    • Active cancer except basal celle carcinoma.
    • Terminal illness with life expectancy of less than 6 months
    • CKD 4 or 5
    • Previous participation
    • AIN associated with glomerulonefritis, sarcoidosis eller inherited interstitial kidney diseases
    • Manglende evne til at afgive informeret samtykke.
    • Immundæmpende behandling inklusiv prednisolon behandling indenfor 3 måneder før nyrebiopsien.
    • Kendt dokumenteret autoimmun sygdom.
    • Allergi overfor indholdsstofferne i forsøgsmedicinen.
    • Intolerance overfor MP eller prednisolon.
    • Manglende vilje til at indtage prednisolon i projektperioden.
    • Graviditet eller amning.
    • Aktiv cancersygdom, bortset fra basalcelle karcinom.
    • Terminal sygdom med forventet restlevetid på mindre end 6 måneder.
    • Kronisk nyresygdom stadie 4 og 5
    • Tidligere deltagelse.
    • AIN ved glomerulonefrit, sarkoidose eller arvelige interstitielle nyresygdomme
    E.5 End points
    E.5.1Primary end point(s)
    o eGFR at 3 months
    eGFR efter 3 mdr
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mdr
    E.5.2Secondary end point(s)
    Kidney function
    CKD stage

    Number og patients in dialysis
    Effekt of treatment delay on outcome

    Urinary biomarkers

    Questionaire: SF36 score
    The predictive value of histopathological evaluation
    Safety endpoints
     P-glukose
     Infections
     submissions
    o Ændring i plasma-kreatinin og eGFR fra indgang i studiet sammenlignet med ved 3 mdr. og 12 mdr. Ved indgang i studiet defineres kreatininen på følgende tidspunkter:
     Højeste målte plasma-kreatinin
     Plasma-kreatinin på biopsi-tidspunkt
     Plasma-kreatinin på dag 0
    o Plasma-kreatinin og eGFR efter 3 og 12 mdr.
    o Hos patienter hvor der forligger vanlig kreatinin.
     Procentdel af patienterne der falder til vanlig plasma-kreatinin eller derunder efter 3 og 12 mdr.
     Ændring i plasma-kreatinin og eGFR efter 3 og 12 mdr. ift vanlig kreatinin
    Vanlig plasma-kreatinin defineres som sidst målte kreatinin hvor patienten klinisk er vurderet i stabil tilstand, dvs. hvor der ikke er inter-kurrerende tilstande der har påvirket nyrefunktionen, inden AIN. Dette vurderes ved anamnesen. Hvis der findes flere målinger indenfor et år inden inklusion vil der tages et gennemsnit af de sidste 3. Hvis der foreligger flere målinger fra samme dag bruges et gennemsnit af disse som en måling.
    o Antallet af patienter der er dialysekrævende ved 3 mdr. og 12 mdr.
    o I prednisolon gruppen analyseres betydningen af ”treatment delay” på øvrige effektparametre. Treament delay defineres som følgende
    • Dage fra symptomstart til opstart af projektmedicin.
    • Dage fra første kontakt med sundhedsvæsenet forløbet relateret til AIN til opstart af projektmedicin.
    • Dage fra første kontakt til nefrologisk afdeling til opstart af projektmedicin.
    o Biomarkører i urin: Koncentrationer i relation til nyrefunktion og prognose
    o Der vil laves korrelationer for årsagen til AIN og øvrige endepunkter
    o SF36 score
    o Den prædiktive værdi af den patologisk vurdering vil blive analyseret, herunder
     Typen af AIN, feks granulomatøs, IgG4
     Tilstedeværelsen af eosinofili
     Tilstedeværelsen og graden af fibrose
     Graden af inflammation
    o Sikkerhedsendpunkter
     P-glukose
     Infektioner.
     Indlæggelser

    For alle parametre gælder at absolutte og relative værdier analyseres hvis muligt
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primarily at3 and 12 months
    And continous measurements
    Primært efter 3 og 12 mdr
    Dedsuden løbende målinger
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Ubehandlet kontrol
    Untreated control
    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 concerned6
    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
    the last visit of the last subject undergoing the trial
    Sidste besøg for den sidste forsøgsperson
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years15
    E.8.9.1In the Member State concerned months
    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: 110
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-04-28. Yes
    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 state110
    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 nephrological care
    Vanlig nefrologsik opfølgning
    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 Decision2017-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    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
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