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    Summary
    EudraCT Number:2020-005445-16
    Sponsor's Protocol Code Number:NL74623.078.20
    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:2021-02-18
    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 number2020-005445-16
    A.3Full title of the trial
    Fasting before live kidney donation, effect on donor wellbeing and postoperative recovery
    Preoperatief vasten voor levende nierdonatie, effect op donor welzijn en postoperatief herstel.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of preoperative fasting on recovery after live kidney donation
    Effect van preoperatief vasten op herstel na nierdonatie
    A.3.2Name or abbreviated title of the trial where available
    FAST-Study
    FAST-Studie
    A.4.1Sponsor's protocol code numberNL74623.078.20
    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 SponsorErasmus MC, University Medical Center Rotterdam
    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 supportErasmus MC, University Medical Center Rotterdam
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC, University Medical Center Rotterdam
    B.5.2Functional name of contact pointPhD-student/ Physician Researcher
    B.5.3 Address:
    B.5.3.1Street AddressDr. Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 GD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310107043541
    B.5.6E-mailc.oudmaijer@erasmusmc.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 Compound Macrogol Oral Powder Sugar Free Macrogol 3350
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Nederland BV, Haarlem, Nederland
    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.3.1Product nameMacrogol 3350
    D.3.2Product code Generic Product
    D.3.4Pharmaceutical form Powder for oral solution in sachet
    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 Yes
    D.3.11.13.1Other medicinal product typeLong, linear non-absorbable and non-metabolizable ethylene glycol polymers
    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
    Preoperative fasting in combination with a low-dose laxative and postoperative recovery and complications in living kidney donors
    Preoperatief vasten in combinatie met een lage dosis laxantia en het postoperatief herstel en complicaties in levende nierdonoren
    E.1.1.1Medical condition in easily understood language
    Preoperative fasting and postoperative recovery after live kidney donation
    Preoperatief vasten en postoperatief herstel na levende nierdonatie
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to determine whether nutritional preconditioning by 2,5 days of fasting and a low dose laxative reduces postoperative fatigue score, 4 weeks after live kidney donation.
    Het primaire doel is om te onderzoeken wat het effect is van nutritionele preconditionering d.m.v. 2,5 dag vasten in combinatie met een lage dosis laxantia op de ernst van de postoperatieve vermoeidheid 4 weken na donornefrectomie.
    E.2.2Secondary objectives of the trial
    to assess the feasibility of the fasting diet, possible side effects/burden, duration of postoperative hospital stay, renal function of donor and transplanted patient and the use of urinary extracellular vesicles in renal transplantation.
    het onderzoeken van de werkbaarheid van het vasten-dieet, mogelijke neveneffecten/last, duur van postoperatieve opnameduur, nierfunctie van de donor en de ontvanger en het gebruik van urinary extracellular vesicles rondom niertransplantatie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients and donors opting for living kidney donation and transplantation at Erasmus MC, University Medical Center in Rotterdam, the Netherlands and University Medical Center Groningen in Groningen, the Netherlands

    In order to be eligible to participate in this study, a subject going for live kidney donation must meet all of the following criteria:
    - Age between 18 and 70 years old
    - BMI between 19 and 35 kg/m2
    - Provide written consent
    Patiënten en donors die voor levende nierdonatie en transplantatie gaan in het Erasmus MC, Universitair Medisch Centrum Rotterdam, Nederland en Universitair Medisch Centrum Groningen in Groningen, Nederland

    Om geïncludeerd te kunnen worden in deze studie, dienen potentiele kandidaten te voldoen aan:
    - Leeftijd tussen 18 en 70 jaar oud
    - BMI tussen 19 en 35 kg/m2
    - Informed Consent
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    - Participants of the cross-over kidney donation program
    - Participation in another prospective trial/study for live kidney donors

    Another exclusion criterium for participation in this study is the use of double anticoagulants (f.i. Ascal (Carbasalate Calcium) and Clopidogrel (Plavix)) in the recipients (to-be-transplanted).
    Een potentiële deelnemer die aan één van de volgende criteria voldoet wordt geexcludeerd van deelname:
    - Deelnemers aan het nationale crossover programma
    - Deelname andere trial

    Een los exclusiecriterium voor deelname in deze studie is het gebruik van dubbele anticoagulantia, bijvoorbeeld Ascal & Clopidogrel in de potentiële ontvangers
    E.5 End points
    E.5.1Primary end point(s)
    Postoperative fatigue, scored by 36-Item Short Form Health Survey (RAND-36)
    Postoperatieve vermoeidheid, gescoord door 36-Item Short Form Health Survey (RAND-36).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be measured 4 weeks after surgery.
    De primaire uitkomst wordt 4 weken na de operatie gemeten.
    E.5.2Secondary end point(s)
    Postoperative fatigue, measured by QoR-40, scored 4 weeks after surgery.

    Postoperative hospital admission time, measured in days since surgery.

    Adherence to the fasting regime

    Physical activity before, during and after hospital stay

    Postoperative recovery of renal function in the donor

    Postoperative recovery of renal function in the transplanted patient

    Determination of upregulation of cytoprotective genes / anti-inflammatory markers

    Investigate the use and merit of uEV in renal transplantation in human subjects and the effect of fasting on uEV
    Postoperatieve vermoeidheid, gemeten dmv QoR-40, 4 weken na operatie

    Postoperatieve duur van ziekenhuisopname, gemeten in dagen sinds de operatie.

    Werkbaarheid / therapietrouw aan het dieet

    Fysieke activiteit voor, tijdens en na ziekenhuisopname en operatie

    Postoperatief herstel van nierfunctie in de donor

    Postoperatief herstel van nierfunctie in de ontvanger

    Determinatie van upregulatie van cytoprotectieve genen / anti inflammatoire markers

    Onderzoeken van het gebruik en nut van urinaire extracellulaire vesicles (uEV) in niertransplantatie in the mens en het effect van vasten op uEV.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within the first week after live kidney donation, or 4 weeks after surgery.
    Binnen de eerste week na levende nierdonatie of 4 weken na de operatie.
    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) 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Geen intake volgens de huidige richtlijnen (6 uur voor de operatie
    Refrain from intake according to usual guidelines (6 hours before surgery)
    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 concerned2
    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
    After the last visit of the last subject (Last visit is 3 months after live kidney donation
    Na de laatste studiegerelateerde afspraak van de laatste proefpersoon. Laatste afspraak is i.p. 3 maanden na levende nierdonatie
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 180
    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 Yes
    F.3.2Patients No
    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 state180
    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)
    Standard of Care:
    Live Kidney donors will be submitted to an annually follow-up in our outpatient department according to protocol.
    Reguliere behandeling;
    Levende nierdonoren zullen jaarlijks vervolgd worden op onze polikliniek volgens de reguliere behandelwijze.
    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 Decision2021-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-23
    P. End of Trial
    P.End of Trial StatusOngoing
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