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    Summary
    EudraCT Number:2007-003885-16
    Sponsor's Protocol Code Number:SVCARB00606
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-12-10
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2007-003885-16
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not on Dialysis
    A.4.1Sponsor's protocol code numberSVCARB00606
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGenzyme Europe BV
    B.1.3.4CountryNetherlands
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 namesevelamer carbonate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNSEVELAMER
    D.3.9.1CAS number 52757956
    D.3.9.3Other descriptive namesevelamer carbonate (mINN)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboTablet
    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
    Treatment of hyperphosphataemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times a day (TID) on serum
    phosphorous levels.
    E.2.2Secondary objectives of the trial
    To compare the effects of sevelamer carbonate dosed TID and placebo dosed TID on the following:
    • Serum total cholesterol and low density lipoprotein (LDL) cholesterol
    • Serum corrected calcium-phosphorous product (CaxP)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet the following criteria to be enrolled in the study:
    1. Willing and able to provide written informed consent.
    2. Men or women 18 years of age or older.
    3. If currently on phosphate binder(s), willing to stop the phosphate binder and enter a 14-21 day Washout Period.
    4. Have been, in the opinion of the Investigator, stable on a phosphate-controlled diet at Screening and be willing to avoid any intentional changes, such as fasting or dieting for the duration of the study.
    5. Have the following central laboratory measurements:
    • If not taking a phosphate binder at Screening, a serum phosphorous measurement ≥4.6 mg/dL (≥1.49 mmol/L) and ≤5.5 mg/dL (≤1.76 mmol/L) at Screening.
    • If taking a phosphate binder at Screening, a serum phosphorous measurement ≥4.6 mg/dL (≥1.49mmol/L) and ≤5.5 mg/dL (≤1.76 mmol/L) after the 14-21 day Washout Period; at the Post-Washout Visit.
    6. Willing and able to take the Investigational Product as a phosphate binder for the duration of the study.
    7. Willing and able to maintain screening doses of lipid-lowering medication for the duration of the study, except for safety reasons.
    8. Willing and able to maintain doses of medication for control of hyperparathyroidism from Screening through Week 12, except for safety reasons.
    9. Willing and able to avoid antacids and phosphate binders containing aluminium, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement.
    10. Willing, if female and of childbearing potential (pre-menopausal and not surgically sterile), to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or intrauterine device(s).
    11. Expecting not to initiate dialysis or have a kidney transplant for the duration of this study.
    12. Be considered compliant with phosphate binders (if applicable).
    13. Has not participated in any other investigational drug studies within 30 days prior to enrolment.
    14. Have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel.
    15. Able to be contacted by phone or other remote means in order to be informed of Investigational Product dose changes.
    E.4Principal exclusion criteria
    Patients will be excluded from this study if they do not meet the specific inclusion criteria, or if they are/have:
    1. Active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.
    2. Previous major gastrointestinal tract surgery.
    3. In the opinion of the Investigator, active ethanol or drug abuser, excluding tobacco use.
    4. Use of anti-arrhythmics for arrhythmias or anti-seizure medications for seizures.
    5. At Screening, the following central laboratory measurements:
    • Serum 25-hydroxyvitamin D <10 ng/mL (<25 nmol/L),
    • Serum intact parathyroid hormone (iPTH) ≥600 pg/mL (≥66 pmol/L), and
    • Serum LDL >140 mg/dL (>3.59 mmol/L).
    6. In the opinion of the Investigator, any clinically significant unstable medical condition, for example:
    poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection.
    7. Pregnant or breast-feeding.
    8. Evidence of active malignancy except for basal cell carcinoma of the skin.
    9. Unable to comply with the requirements of the study.
    10. A known hypersensitivity to the Investigational Product or any of its constituents.
    11. Any other condition, which in the opinion of the Investigator, would mean participation in the study would not be in the patient’s best interest.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is serum phosphorous change from Baseline to Week 12/Titration Period Early Termination (TPET).
    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.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 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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 Information not present in EudraCT
    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
    Data base lock
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.3Elderly (>=65 years) Yes
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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 Decision2009-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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