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    Summary
    EudraCT Number:2012-001909-24
    Sponsor's Protocol Code Number:Spartacus/007
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-27
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-001909-24
    A.3Full title of the trial
    A Multi Center, Prospective, Observational, Open-label, Pharmacokinetic Study of Tacrolimus in Heart and Lung Transplantation Patients during the First Days after Transplantation
    Een multi centrum, prospectief, observationeel, open label, pharmacokinetische studie van tacrolimus in hart en longtransplantatie patiënten gedurende de eerste dagen na transplantatie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetics of tacrolimus in the first days after heart and lung transplantation
    Farmacokinetiek van tacrolimus in de eerste dagen na hart en long transplantatie
    A.3.2Name or abbreviated title of the trial where available
    Spartacus
    Spartacus
    A.4.1Sponsor's protocol code numberSpartacus/007
    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 Medical Center Utrecht
    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 supportUniversity Medical Center Utrecht
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht
    B.5.2Functional name of contact pointNational Poisons Information Center
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00318875585611
    B.5.5Fax number0031882541511
    B.5.6E-mailm.a.sikma@umcutrecht.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 Prograft®, tacrolimus
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe BV
    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 nametacrolimus
    D.3.2Product code RVG222236 and RVG18107
    D.3.4Pharmaceutical form Capsule, hard
    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 INNtacrolimus
    D.3.9.1CAS number 104987-11-3
    D.3.9.3Other descriptive nameFK506
    D.3.9.4EV Substance CodeSUB10797MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Heart and lung transplantation, first days after transplantation
    Hart en long transplantatie, eerste dagen na transplantatie
    E.1.1.1Medical condition in easily understood language
    Heart and lung transplantation, first days after transplantation
    Hart en long transplantatie, eerste dagen na transplantatie
    E.1.1.2Therapeutic area Body processes [G] - Physical Phenomena [G01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10053349
    E.1.2Term Pharmacokinetic study
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective:
    To show that the variability of whole blood total and unbound plasma tacrolimus concentrations during the first 6 days post transplantation is larger than the variation of tacrolimus concentrations in stable clinical situation.

    Primaire doel:
    Het aantonen dat de variabiliteit van volbloed totale en ongebonden plasma tacrolimus concentraties gedurende de eerste dagen na transplantatie groter is dan de tacrolimus concentraties in een stabiele klinische situatie

    E.2.2Secondary objectives of the trial
    Secondary objectives:
    • To show that unbound tacrolimus plasma concentrations can better predict the occurrence of renal dysfunction than whole blood total tacrolimus concentrations.
    • Identification of variables influencing the unbound tacrolimus plasma concentrations.
    • To evaluate whether variations in tacrolimus concentrations in the first days after lung transplantation in cystic fibrosis patients are higher than without cystic fibrosis.


    Long-term objective:
    • The data will be used to develop a kinetic model in the future in order to dose tacrolimus more accurately to prevent adverse effects of tacrolimus.
    Secundaire doelen:
    • Aantonen dat de ongebonden tacrolimus plasma concentraties nierfunctiestoornissen better voorspellen dan volbloed totale tacrolimus concentraties
    • Het identificeren van variabelen die de ongebonden tacrolimus plasma concentraties beïnvloeden
    • Aantonen dat de variaties in tacrolimus concentraties in de eerste dagen na long transplantatie in cystic fibrose patiënten groter zijn dan zonder cystic fibrose


    Lange termijn doel:
    • De data zullen gebruikt worsen om een farmacokinetisch model te maken in de toekomst ter verbetering van het doseren van tacrolimus om bijwerkingen van tacrolimus te voorkomen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients ≥ 18 years
    • Patients admitted to the ICC of UMCU after heart or lung transplantation
    • Treated with tacrolimus (Prograft®; Astellas Pharma Europe)
    • Informed consent obtained
    • Patiënten ≥ 18 jaar
    • Patiënten opgenomen op de intensive care van het UMCU na hart of long transplantatie
    • Behandeling met tacrolimus (Prograft®; Astellas Pharma Europe)
    • Informed consent verkregen
    E.4Principal exclusion criteria
    • Patients < 18 years
    • Patients who die within one day after admission to the ICC of UMCU
    • Withdrawal of informed consent
    • Allergy towards tacrolimus or macrolides
    • Patients on total parenteral nutrition
    • Patiënten < 18 jaar
    • Patiënten die overlijden binnen een dag na opname op de intensive care van het UMCU
    • Intrekking van het informed consent
    • Allergie voor tacrolimus of macrolides
    • Patiënten behandeld met totale parenterale voeding
    E.5 End points
    E.5.1Primary end point(s)
    The endpoints are whole blood total tacrolimus concentrations and unbound tacrolimus plasma concentrations together with the pharmacokinetic parameters: AUC, Cmin, Cmax, Tmax, T1/2, Vd, CL, CL/F (=oral clearance).
    De uitkomstmaten van de studie zijn de volbloed totale tacrolimus concentraties en ongebonden tacrolimus plasma concentraties samen met de volgende farmacokinetische parameters: AUC, Cmin, Cmax, Tmax, T1/2, Vd, CL, CL/F (=orale klaring).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-6, 30, 90 and 180 days after transplantation
    1-6, 30, 90 and 180 dagen na transplantatie
    E.5.2Secondary end point(s)
    Variables influencing unbound plasma tacrolimus concentrations:
    • Renal dysfunction
    • Erythrocytes or Hematocrit
    • Albumin
    • alpha-1-Acid glycoprotein
    • High density lipoprotein
    • pH
    • Daily fluid balance and body weight
    • CYP3A4/CYP3A5 gene expression, and P-glycoprotein gene expression
    • Hepatic dysfunction: bilirubin and ALAT will be used to quantify hepatic dysfunction
    • Diarrhoea or ileus
    • Cystic fibrosis
    • Plasma concentrations of (val)acyclovir, (val)ganciclovir, tobramycin and trimethoprim/sulfamethoxazole, if administered, will be measured at steady state as possible additional factor causing kidney dysfunction
    Variabelen die de ongebonden tacrolimus plasma concentratie beïnvloeden:
    • Nierfunctie stoornissen
    • Erythrocyten of hematocriet
    • Albumine
    • Alpha-1-Acid glycoproteïne
    • High density lipoproteïne
    • pH
    • Dagelijkse vloeistof balans en lichaamsgewicht
    • CYP3A4/CYP3A5 gen expressie, and P-glycoproteïne gen expressie
    • Leverfunctiestoornissen: bilirubine and ALAT zullen worden gebruikt om leverfunctiestoornissen te definiëren
    • Diarree of ileus
    • Cystic fibrose
    • Plasma concentraties van (val)acyclovir, (val)ganciclovir, tobramycin en trimethoprim/sulfamethoxazole, indien toegediend, zullen gemeten worden in steady state als mogelijke additionele factor voor nierfunctiestoornissen
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-6, 30, 90 and 180 days after transplantation
    1-6, 30, 90 and 180 dagen na transplantatie
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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 No
    E.8.1.1Randomised No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    LVLS
    LVLS
    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 months0
    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: 30
    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 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 state30
    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)
    After the trial all transplantation patients will be treated life long according to the transplantation protocol
    Na de studie zullen alle transplantatiepatienten volgens het transplantatieprogramma levenslang behandeld worden
    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 Decision2012-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-14
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