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    Summary
    EudraCT Number:2011-005017-37
    Sponsor's Protocol Code Number:TheDIPAK1study
    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:2012-05-21
    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 number2011-005017-37
    A.3Full title of the trial
    A randomised, controlled clinical trial assessing the efficacy of
    Lanreotide to halt disease progression in ADPKD
    Een gerandomiseerde klinische studie die de effectiviteit van Lanreotide onderzoekt om ziekte progressie in ADPKD patienten te remmen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To investigate the effect of Lanreotide on renal function decline in ADPKD patients
    Onderzoek naar het effect van Lanreotide op achteruitgang van
    nierfunctie bij patiënten met ADPKD.
    A.3.2Name or abbreviated title of the trial where available
    The DIPAK 1 Study
    De DIPAK 1 studie
    A.4.1Sponsor's protocol code numberTheDIPAK1study
    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 SponsorDIPAK Consortium
    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 supportNierstichting
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDipak Consortium
    B.5.2Functional name of contact pointCoordinator
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310503614396
    B.5.5Fax number00310503619067
    B.5.6E-mailesther.meijer@umcg.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 Somatuline Autogel
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Group B.V.
    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 nameLanreotide
    D.3.2Product code BIM 23014
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLanreotide
    D.3.9.1CAS number 127984-74-1
    D.3.9.3Other descriptive nameLANREOTIDE ACETATE
    D.3.9.4EV Substance CodeSUB14326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number155.5
    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
    First, to demonstrate whether Lanreotide attenuates progression of the renal phenotype in ADPKD patients as measured
    by change in rate of renal function decline and change in renal volume. Second, to demonstrate whether Lanreotide
    modifies progression of the liver phenotype in the subset of ADPKD patients with moderate to severe polycystic liver
    disease as measured by change in liver volume.
    Het primaire doel is om aan te tonen dat Lanreotide progressie van nierziekte bij ADPKD patiënten kan vertragen,
    gemeten als verandering in de snelheid van nierfunctie achteruitgang en groeisnelheid van niervolume. Het tweede doel is
    om aan te tonen dat Lanreotide de progressie van de leverziekte vermindert in de subgroep van patiënten met ADPKD
    matige tot ernstige polycysteuze leverziekte, gemeten als verandering in levervolume.
    E.1.1.1Medical condition in easily understood language
    The first aim of this study is to investigate whether Lanreotide can prevent renal function decline in ADPKD patients.
    Het eerste doel van dit onderzoek is om aan te tonen dat Lanreotide beschermend kan zijn voor de nier in ADPKD.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10023433
    E.1.2Term Kidney polycystic
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic 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 demonstrate whether Lanreotide modifies progression of the renal phenotype in ADPKD patients as measured by change in rate of renal function decline and kidney
    volume growth.
    Het primaire doel is om aan te tonen dat Lanreotide progressie van nierziekte bij ADPKD patiënten kan vertragen,
    gemeten als verandering in de snelheid van nierfunctie achteruitgang en groeisnelheid van niervolume.
    E.2.2Secondary objectives of the trial
    To demonstrate whether Lanreotide modifies progression of the liver phenotype in the subset of ADPKD patients with moderate to severe polycystic liver disease as measured by change in rate of liver volume growth.
    Het tweede doel is om aan te tonen dat Lanreotide de progressie van de leverziekte vermindert in de subgroep van patiënten met ADPKD matige tot ernstige polycysteuze leverziekte, gemeten als verandering in levervolume.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of ADPKD, based upon the modified Ravine criteria
    2. Age between 18 and 60 years.
    3. eGFR (MDRD) between 30 and 60 mL/min/1.73 m2.
    4. Providing informed consent.
    1. Diagnose ADPKD, gebaseerd op de aangepaste Ravine criteria
    2. Leeftijd tussen 18 en 60 jaar.
    3. eGFR (MDRDI) tussen 30 en 60mL/min/1.73m2.
    4. Informed consent getekend
    E.4Principal exclusion criteria
    1. Patients who, in the opinion of the study investigator may present a safety risk.
    2. 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).
    3. Patients taking medications or having concomitant illnesses likely to confound endpoint assessments (e.g.
    nephrotoxic medications such as chronic NSAID, cyclosporine, lithium immunosuppressant use, and e.g. diabetes
    mellitus and patients with proteinuria > 1 g /24hr).
    4. Patients who underwent surgical or drainage interventions for cystic kidney disease the year before study-entry
    or are likely candidates for these procedures within 2 years of start of the study.
    5. Patients taking other experimental (i.e., non marketed) therapies.
    6. Patients having used Lanreotide (or another somatostatin analogue) in the 3 months before study start.
    7. Patients known with intolerance for Lanreotide (or another somatostatin analogue).
    8. Unwillingness to comply with reproductive precautions. Women who are capable of becoming pregnant must be
    willing to comply with approved birth control from two-weeks prior to, and for 60 days after taking investigational
    product.
    9. Women, who are pregnant or breastfeeding.
    10. Patients, who suffer from cardiac arrhythmia’s, with the exception of stable atrial fibrillation.
    11. Patients, who ever suffered from symptomatic gallstones, with the exception of patients who underwent a cholecystectomy.
    12. Patients, who have a medical history of pancreatitis.
    1. Patienten, welke naar bevinden van de onderzoekers een veiligheidsrisico kunnen vormen
    2. Patiënten, die waarschijnlijk de studie procedures niet in acht nemen (vanwege bijvoorbeeld medische
    aandoeningen waarvoor een langere onderbreking of beëindiging, middelenmisbruik of niet-medicatie trouw)
    3. Patienten met medicatie of andere ziektes die de eindpunten van de studie kunnen verstoren, bijv. diabetes
    mellitus, >1 gram proteinurie per 24h, gebruik van nefrotoxische medicijnen, bijv. chronisch NSAID gebruik,
    cyclosporine, lithium, immunosuppresiva
    4. patienten die chirurgische of radiologische interventies van het niervolume hebben ondergaan het jaar
    voorafgaand aan studie deelname of van wie verwacht wordt dat ze dat in de komende 2 jaar zullen ondergaan.
    5. Patienten die aan andere (experimentele) studies deelnemen
    6. patienten die lanreotide gebruiktes in de 3 maanden voorafgaand aan studie deelname
    7. patienten van wie bekend is dat zij lanreotide niet kunnen verdragen.
    8. Patienten, die niet bereid zijn om anti-conceptie maatregelen in acht te nemen. Vrouwen in de vruchtbare
    periode mogen niet zwanger worden twee weken voor en 60 dagen na het nemen van de studiemedicatie.
    9. Vrouwen, die borstvoeding geven.
    10. Patienten, die cardiale ritmestoornissen hebben, met als uitzondering stabiel atriumfibrilleren
    11. Patienten, die ooit symptomatisch galsteenlijden hebben gehad, behalve patienten die een cholecystectomie hebben ondergaan.
    12. Patienten, met een voorgeschiedenis van pancreatitis.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in change in renal function in lanreotide versus not treated patients, as assessed as slope through serial eGFR
    measurements over time, with the value obtained at month 3 as first eGFR and the last eGFR available as last eGFR
    measurement for slope analysis.
    De belangrijkste studie parameter zal de verandering in nierfunctie zijn. Deze wordt per patient beoordeeld als
    regressielijn door opeen volgende eGFR metingen in de tijd. Het startpunt is de eGFR op 3 maanden behandeling en het
    eindpunt is de laatste beschikbare eGFR waarde.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study, when all patients have finished the protocol.
    Aan het einde van de studie, wanneer alle deelnemers de studie beeindigd hebben.
    E.5.2Secondary end point(s)
    • change in renal volume (MRI),
    • change in liver volume (MRI) in the subset of ADPKD patients with moderate tot severe polycystic liver disease
    • quality of life (questionnaires)
    • tolerability of Lanreotide
    • verandering in niervolume (MRI),
    • verandering in levervolume (MRI) in de subgroep van ADPKD patiënten met matig tot ernstige polycysteuze leverziekte
    • kwaliteit van leven (vragenlijsten)
    • verdraagzaamheid van Lanreotide
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study, when all patients have finished the protocol.
    Aan het einde van de studie, wanneer alle deelnemers de studie beeindigd hebben.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standaard zorg
    standard care
    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 concerned4
    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
    End of the study will be when all patients have finished the protocol including the follow-up visit.
    het einde van de studie is, wanneer alle patienten het protocol doorlopen hebben inclusief het follow-up bezoek.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 300
    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 state300
    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)
    To continue off-label use of lanreotide until the results of the first trial are known.
    Aan patienten zal na afloop van de studie lanreotide offlabel voorgeschreven kunnen worden als patienten dit willen.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-30
    P. End of Trial
    P.End of Trial StatusOngoing
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