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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
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    EudraCT Number:2015-002488-40
    Sponsor's Protocol Code Number:LIPMAT
    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:2015-09-01
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-002488-40
    A.3Full title of the trial
    The LIPMAT study: Liposomal prednisolone to improve hemodialysis fistula maturation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LIPMAT: liposomal prednisolone to improve the quality of a vascular access for hemodialysis
    LIPMAT: liposomaal prednisolon ter bevordering van de kwaliteit van de vaattoegang voor hemodialyse
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberLIPMAT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02495662
    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 SponsorLeiden University Medical Center
    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 supportEnceladus Pharmaceuticals B.V.
    B.4.1Name of organisation providing supportLeiden University Medical Center
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointDepartment of Nephrology - LIPMAT
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 ZA
    B.5.4Telephone number31715262148
    B.5.5Fax number31715266868
    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 No
    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 namePEG-liposomal prednisolone sodium phosphate
    D.3.2Product code GLPG0303
    D.3.4Pharmaceutical form Dispersion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNanocort
    D.3.9.1CAS number 125-02-0
    D.3.9.2Current sponsor codeGLPG0303
    D.3.9.3Other descriptive namePREDNISOLONE SODIUM PHOSPHATE
    D.3.9.4EV Substance CodeSUB04018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.6
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nonmaturation of arteriovenous vascular accesses for hemodialysis.
    Maturatiefalen van arterioveneuze fistels voor hemodialyse.
    E.1.1.1Medical condition in easily understood language
    Early failure of vascular accesses for renal replacement therapy.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10019480
    E.1.2Term Hemodialysis
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess if liposomal prednisolone, administered to patients after creation of a radiocephalic AVF for hemodialysis, promotes AVF maturation as measured by venous diameter after 6 weeks.
    Evalueren of liposomaal prednisolon effectief is ter verbetering van shuntmaturatie na chirurgische aanleg van een radio-cephalica shunt.
    E.2.2Secondary objectives of the trial
    1. To assess the AVF flow and diameter at 6 weeks and 3 months.
    2. To assess safety outcomes.
    3. To assess the correlation between pre-operative venous calcification and AVF maturation (exploratory).
    4. To assess the correlation between in vitro complement activation and in vivo complement activation and infusion reactions (exploratory).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who are scheduled for creation of a radiocephalic AVF for maintenance hemodialysis.
    2. Male or female ≥ 18 years old.
    3. Patients are able and willing to give written informed consent.
    1. Patiënten bij wie de aanleg van een radio-cephalica shunt voor chronische hemodialyse gepland is.
    2. Mannen of vrouwen met een leeftijd ≥ 18 jaar.
    3. Patiënten zijn in staat en bereid om schriftelijke toestemming (informed consent) te geven.
    E.4Principal exclusion criteria
    1. Any concurrent illness, disability or clinically significant abnormality that may, as judged by the investigator, affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol.
    2. Current participation in another interventional clinical trial or subjects who have received an investigational drug within 30 days prior to the baseline visit.
    3. History of psychosis.
    4. History of osteonecrosis
    5. Previous AVF in the ipsilateral arm.
    6. Current central venous catheter at the ipsilateral side.
    7. Treatment with oral, rectal or injectable (including intra-articular) glucocorticoids (CS) within 6 weeks prior to baseline visit. Inhaled glucocorticoids are allowed. Topical steroids are allowed, however subjects should not have received more than 100 gram of a mild to moderate topical corticosteroid cream per week, 50 gram of a potent corticosteroid cream per week or 30 gram of a very potent topical corticosteroid cream per week in the 4 weeks prior to the baseline visit.
    8. Treatment with immunosuppressant drugs. Treatment with NSAIDs.
    9. Patients who are unlikely to adequately comply with the trial’s procedures (due for instance to medical conditions likely to require an extended interruption or discontinuation, history of substance abuse or noncompliance).
    10. Women who are lactating, pregnant (positive pregnancy test at baseline) or planning to become pregnant during the course of the study.
    11. Unwillingness to use reliable and acceptable contraceptive methods throughout the study and till 3 months after last study medication except for female patients who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or at least 1 year postmenopausal.
    12. Malignant disease, unless cured. Current prostate carcinoma without current or planned cytostatic therapy is allowed.
    13. Diabetes mellitus, unless on a stable dose of antidiabetic medication or insulin for at least 4 weeks prior to inclusion.
    14. Signs of active infection, requiring systemic treatment.
    15. Positive Quantiferon test.
    16. Subject with positive hepatitis panel (including hepatitis B surface antigen [HBsAg], and / or anti-hepatitis B core antibodies, and / or hepatitis C virus antibody [anti-HCV]).
    17. History of anaphylaxis or severe allergic responses, including to radio-contrast agents.
    18. Planned live-virus vaccinations.
    19. Planned surgical interventions or planned elective hospital admissions within 6 weeks after AVF surgery. Planned hemodialysis sessions do not count as an exclusion criterion.
    20. Abnormal hepatic function (ALT/AST or bilirubin > 2 x upper limit of normal) at the time of the screening visit.
    21. Clinically significant out-of-range values on hematology panel, at discretion of the Principal Investigator.
    22. Current substance abuse or alcohol abuse.
    1. Een ziekte, handicap of klinisch belangrijke afwijking die, naar het oordeel van de onderzoeker, de interpretatie van klinische effectiviteits- of veiligheidsgegevens kan beïnvloeden of veilige deelname aan de onderzoekshandelingen kan beperken.
    2. Gelijktijdige deelname in een ander klinisch interventie-onderzoek of personen die minder dan 30 dagen voor screening een ander onderzoeksgeneesmiddel toegediend hebben gekregen.
    3. Psychose in de voorgeschiedenis.
    4. Osteonecrose in de voorgeschiedenis.
    5. Eerdere aanwezigheid van een arterioveneuze shunt in de ipsilaterale extremiteit.
    6. Actuele aanwezigheid van een centraalveneuze catheter aan de ipsilaterale zijde.
    7. Behandeling met orale, rectale of injecteerbare (inclusief intra-articulaire) glucocorticoïdenminder dan zes weken voor de screening. Inhalatieglucocorticoïden zijn toegestaan. Dermale glucocorticoïden zijn toegestaan, mits de totale dosis minder is dan 100 gram per week voor mild (klasse 1) tot matig (klasse 2) werkende glucocorticoïden, 50 gram per week voor sterk (klasse 3) werkende glucocorticoïden of 30 gram per week voor zeer sterk (klasse 4) werkende glucocorticoïden in de vier weken voor de screening.
    8. Behandeling met immunosuppressiva. Behandeling met NSAIDs.
    9. Proefpersonen waarvan het onwaarschijnlijk is dat zij de onderzoekshandelingen volledig zullen ondergaan (bijvoorbeeld door comorbiditeiten waarbij een langdurige onderbreking of staken van de onderzoekshandelingen te verwachten is of een voorgeschiedenis van middelenmisbruik of therapie-ontrouw).
    10. Vrouwen die borstvoeding geven, zwanger zijn (positieve zwangerschapstest bij screening) of voornemens zijn zwanger te worden gedurende het onderzoek.
    11. Onbereidheid om veilige en acceptabele anticonceptiva te gebruiken gedurende het onderzoek tot drie maanden na de laatste behandeling, behalve voor vrouwen die chirurgisch onvruchtbaar zijn (bilaterale tubaligatie, bilaterale oophorectomie, hysterectomie) of tenminste een jaar postmenopauzaal zijn.
    12. Maligniteit, tenzij gecureerd. Een actueel prostaatcarcinoom zonder actuele of geplande chemotherapie is toegestaan.
    13. Diabetes mellitus, tenzij ingesteld op een stabiele dosering antidiabetische medicatie of insuline gedurende tenminste vier weken voor inclusie.
    14. Tekenen van een actieve infectie, waarvoor systemische behandeling noodzakelijk is.
    15. Positieve Quantiferon-test.
    16. Proefpersonen met een positieve hepatitis-screening (waaronder Hepatitis B oppervlakte-antigeen (HBsAg) en/of anti-hepatitis B kern-antistoffen en/of hepatitis C antistoffen (anti-HCV).
    17. Voorgeschiedenis van anafylaxie of ernstige allergische reacties, waaronder tegen contrastmiddelen.
    18. Geplande vaccinaties met levend virus-vaccins.
    19. Geplande chirurgische ingrepen of geplande electieve ziekenhuisopnames binnen zes weken na shuntchirurgie. Geplande hemodialyse-sessies gelden niet als exclusiecriterium.
    20. Afwijkende leverfunctietests (ASAT/ALAT of bilirubine >2 x bovengrens van referentiewaarden) bij screening.
    21. Klinisch belangrijk afwijkende waarden in de bloedceltelling, naar het oordeel van de onderzoeker.
    22. Actueel middelenmisbruik, waaronder alcoholmisbruik.
    E.5 End points
    E.5.1Primary end point(s)
    Cephalic vein diameter, assessed by duplex ultrasound.
    De diameter van de vena cephalica, beoordeeld met echografie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Six weeks after surgery.
    Zes weken na chirurgie.
    E.5.2Secondary end point(s)
    Duplex ultrasound measurements
    - Cephalic vein diameter
    - Per-patient change of cephalic vein diameter
    - Radial artery diameter
    - Radial artery flow
    Echo-duplex metingen 6 weken en 3 maanden na chirurgie:
    - Vena cephalica diameter (waar 6 weken het primaire eindpunt is).
    - Per-patient verandering van vena cephalica diameter.
    - Arteria radialis diameter.
    - Arteria radialis flow.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 weeks and 3 months after surgery.
    6 weken en 3 maanden na chirurgie.
    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 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. 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 concerned5
    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 Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state80
    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)
    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 Decision2015-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-06
    P. End of Trial
    P.End of Trial StatusOngoing
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