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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   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).

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    Summary
    EudraCT Number:2011-002586-38
    Sponsor's Protocol Code Number:RPH-1101
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-08-24
    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 ConcernedSweden - MPA
    A.2EudraCT number2011-002586-38
    A.3Full title of the trial
    A 12-week clinical double-blind, randomised study of cholecalciferol versus placebo in patients with chronic kidney disease stage 3-4 (CHICK).
    En 12-veckors clinisk, dubbel-blind, randomiserad studie av cholecalciferol och placebo hos patienter med kronisk njursvikt, stadium 3-4.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-week clinical double-blind, randomised study of vitamin D versus placebo in patients with chronic kidney disease stage 3-4 (CHICK).
    12-veckors clinisk, dubbel-blind, randomiserad studie av vitamin D och placebo hos patienter med kronisk njursvikt, stadium 3-4.
    A.3.2Name or abbreviated title of the trial where available
    Vitamin D in chronic kidney disease
    Vitamin D vid kronisk njursvikt
    A.4.1Sponsor's protocol code numberRPH-1101
    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 SponsorRenapharma AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRenapharma AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMonitour AB
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressSmedjegatan 7
    B.5.3.2Town/ cityKarlstad
    B.5.3.3Post codeSE-65218
    B.5.3.4CountrySweden
    B.5.4Telephone number+4654217575N/A
    B.5.5Fax number+4654217405N/A
    B.5.6E-maillennart.jonsson@monitour.se
    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 Detremin 20,000 I.U./ml oral drops, solution
    D.2.1.1.2Name of the Marketing Authorisation holderRenapharma AB (Sweden)
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameVitamin D3 Forte Renapharma
    D.3.2Product code Vitamin D3 Forte Renapharma
    D.3.4Pharmaceutical form Oral drops, solution
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboOral solution
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral drops, solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic renal failure, stage 3-4
    Kronisk njursvikt, stadium 3-4
    E.1.1.1Medical condition in easily understood language
    Chronic renal failure, stage 3-4
    Kronisk njursvikt, stadium 3-4
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10038444
    E.1.2Term Renal failure chronic
    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 whether there is a difference in the mean change from baseline of the blood levels of parathyroid hormone (PTH) between patients receiving cholecalciferol compared with patients receiving cholecalciferol placebo after 12 weeks’ treatment.
    Att undersöka om det finns någon skillnad i medelförändring i blodnivåer av parathormon mellan startpunkt och efter 12 veckors behandling med cholecalciferol (vitamin D) eller placebo.
    E.2.2Secondary objectives of the trial
    The following secondary variable will be assessed after 6 weeks:
    • Mean change in blood levels of PTH.
    Further, the following secondary variables will be assessed after 6 and 12 weeks:
    • To Investigate whether there is a difference between the two treatment groups with respect to change in PTH levels after 6 weeks, and to investigate individual changes. Further to investigate differences between the two treatment in the change from baseline in musculoskeletal function and fatigue.
    Följande sekundära variabel kommer att mätas efter 6 veckor:
    * medelförändring i blodnivåer av parathormon
    Följande sekundära variabler kommer att undersökas efter 6 resp. 12 veckor:
    * Skillnaden mellan grupperna avseende förändring i nivåer av parathormon efter 6 veckor och även individuella skillnader.Dessutom kommer de två behandlingarna att jämföras avseende funktion hos skelettmuskulatur och trötthet efter 6 resp. 12 veckor.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Males or females aged 18-85
    • A calculated GFR of 59 to 15 mL/min/1.73 m2 body surface according to the Modification of Diet in Renal Disease (MDRD) formula
    • Intact PTH above 6.8 pmol/L (70 pg/mL)
    • Calcidiol levels below 75 nmol/L (30 ng/mL)
    • Have signed informed consent to participate in the study
    • Män och kvinnor 18-85 år
    • Beräknat GFR mellan 59-15 mL/min/1.73 m2 kroppsyta enligt MDRD formeln
    • Intakta PTH-nivåer över 6.8 pmol/L (70 pg/mL)
    • Calcidiol nivåer understigande 75 nmol/L (30 ng/mL)
    • Har undertecknat skriftligt samtycke att delta i studien
    E.4Principal exclusion criteria
    • Assumed need for dialysis or renal transplantation within six months
    • Ionized calcium above 1.30 mmol/L
    • Ongoing acute infectious or inflammatory disease. Ongoing chronic inflammatory disease other than chronic glomerulonephritis or systemic diseases with renal involvement
    • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
    • Kidney transplant, known granulomatous disease, malabsorption, primary hyperparathyroidism, malignancy or other disease with effect on mineral metabolism
    • Ongoing treatment with parakalcitol, calcimimetics or a daily intake of pharmaceutical preparations containing >400 IE of vitamin D.
    • Planned vacation trip, during the study period, to a sunny country outside Sweden
    • Contraindication for Vitamin D3 Forte Renapharma®
    • Antaget behov av dialys eller njurtransplantation inom 6 månader.
    • Nivå av joniserat calcium mer än 1.30 mmol/L
    • Pågående akut infektiös eller inflammatorisk sjukdom. Pågående annan kronisk inflammatorisk sjukdom än glomerulonefrit eller annan systemsjukdom med njurpåverkan.
    • Fertila kvinnor som ammar eller är gravida eller avser att bli gravida eller inte använder antikonception.
    • Njurtransplantation, känd granulomatös sjukdom, malabsorption, primär hyperparathyroidism, malignitet eller annan sjukdom med effect på mineral metabolismen
    • Pågående behandling med parakalcitol, calcimimetika eller ett dagligt intag av farmaceutiska beredningar som innehåller >400 IE of vitamin D.
    • Plannerad semesterresa, under studienperioden, till ett soligt land utanför Sverige.
    • Kontraindikationer for Vitamin D3 Forte Renapharma®
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline in the levels of PTH after 12 weeks’ treatment
    Medelförändring i nivåer av parathormon från behandlingsstart och efter 12 veckors behandling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 12 weeks´ of treatment
    Efter 12 veckors behandling
    E.5.2Secondary end point(s)
    Secondary efficacy variables: Mean change from baseline after 6 to 12 weeks in the levels of grip strength, fatigue questionnaire, fatigue on visual analogue scale. Exploratory analyses: calcidiol and calcitriol levels, biointact (1-84) PTH, FGF23, ionized calcium, phosphate (Pi), GFR estimated from cystatin C levels, and renal fractional excretion (FE) of Ca and Pi.
    Medelförändring från behandlingsstart och efter 6 och 12 veckors behandling avseende gripstyrka och trötthet mätt med en visuell analogskala.
    Explorativa anlyser är: calcidiol, calcitriol levels, biointakt (1-84) PTH, FGF23, ioniserat calcium, fosfat (Pi), GFR mätt med hjälp av cystatin C levels och fraktionerad renal utsöndring (FE) av Ca and Pi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 6 and 12 weeks respectively
    Efter 6 resp. 12 veckor
    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 No
    E.6.5Efficacy No
    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 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 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
    Study ends after 12 weeks´ treament for each patient. The active IMP is approved for the market and the patient may continue treatment after the end of the study at the discretion of the investigator/treating physician.
    Studien avslutas efter 12 veckors behandling för varje patient. Studiepreparatet finns godkänt på marknaden och prövaren avgör för varje patient om han eller hon skall fortsätta med D-vitaminbehandling inom ramen för ordinarie förskrivning.
    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 months1
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days1
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 participation in the trial, the patients may bwe treated with the approved product at the discretion of the investigator/physician.
    Efter studiens slut kan patienten fortsätta med den godkända produkten, om så bedöms lämpligt av prövaren eller patientens ordinarie läkare.
    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 Decision2011-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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