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    Summary
    EudraCT Number:2007-003364-21
    Sponsor's Protocol Code Number:MCI-196-E11
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-16
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2007-003364-21
    A.3Full title of the trial
    A Phase III, Multicentre, Double-blind, Double-Dummy, Randomised, Flexible-dose, Comparative Study of MCI-196 versus Simvastatin for the Treatment of Dyslipidaemia in Subjects with Chronic Kidney Disease on Dialysis (incorporating a Placebo-controlled Withdrawal Phase)
    A.4.1Sponsor's protocol code numberMCI-196-E11
    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 SponsorMitsubishi Tanabe Pharma Corporation
    B.1.3.4CountryJapan
    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 Yes
    D.2.1.1.1Trade name CHOLEBINE®
    D.2.1.1.2Name of the Marketing Authorisation holderMitsubishi Tanabe Pharma Corporation
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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.3.2Product code MCI-196
    D.3.4Pharmaceutical form Film-coated 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 INNcolestilan
    D.3.9.1CAS number 95522-45-5
    D.3.9.2Current sponsor codeMCI-196
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Simvastatin
    D.2.1.1.2Name of the Marketing Authorisation holderFarmaprojects, S.A.
    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 nameSimvastatin
    D.3.4Pharmaceutical form Film-coated 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 INNSimvastatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboFilm-coated tablet
    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 placeboFilm-coated tablet
    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
    Dislipidaemia in subjects with Chronic Kidney Disease on Dialysis.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10058108
    E.1.2Term Dyslipidaemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum LDL-C in subjects with Chronic Kidney Disease Stage V on dialysis.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of MCI-196 over placebo in modifying other lipid parameters (including total cholesterol, HDL-C, and triglycerides)
    • To evaluate the comparative efficacy of MCI-196 versus simvastatin with regard to other lipid parameters.
    • To evaluate the safety and tolerability of MCI-196, compared to both placebo and simvastatin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for participation in this study at Screening if all the following criteria are met:
    1. The subject is capable of reading and comprehending the informed consent and complying with study procedures, and provides written informed consent.
    2. The subject is male or female, 18 years of age or over.
    3. The subject has a diagnosis of Chronic Kidney Disease Stage V as defined by the K/DOQI Guidelines and is on dialysis.
    4. The subject is clinically stable (as judged by the Investigator) on haemodialysis or peritoneal dialysis for at least 3 months prior to screening.
    5. The subject is undergoing regular dialysis treatment:
    - If the subject is on haemodialysis, this should be scheduled to occur 3 times per week in a hospital or centre setting. The duration must be between 3 to 6 hours or
    if high-flux dialysis, a minimum of 2.5 hours, depending on the standard of care in each centre.
    - If the subject is on peritoneal dialysis, this should be scheduled to be either daily APD (Automated Peritoneal Dialysis) or CAPD (Continuous Ambulatory Peritoneal Dialysis), the latter employing at least 3 bag changes per day.
    6. The subject has calcium dialysate content between 1.00 and 1.75 mmol/L (2.0 to 3.5 mEq/L), depending on the standard of care in each centre. Calcium dialysate content should remain constant for the duration of the study.
    7. The subject has baseline Kt/V (single pool) of at least 1.2 for haemodialysis subjects, and a weekly Kt/V value of at least 1.8 for peritoneal dialysis subjects.
    8. The subject, if female and of child-bearing potential, has a negative serum pregnancy test. Sexually active females must agree to take appropriate steps not to become pregnant during the course of the clinical study.

    A subject will be eligible for randomisation into this study if the following criteria are met:
    • Both LDL-C levels at Week -2 and Week -1 are greater than or equal to 2.59 mmol/L(100 mg/dL) The lower LDL-C value must be within a 20% range of the higher value.
    E.4Principal exclusion criteria
    1. The subject has current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
    2. The subject has a serum albumin level less than 30.0 g/L (<30 g/L).
    3. The subject has a history of PTH levels consistently/frequently >1000 pg/mL.
    4. The subject has a serum triglycerides level > 6.76 mmol/L (600 mg/dL)
    5. The subject has a body mass index (BMI) less than or equal to 16.0 kg/m2 or greater than or equal to 40.0 kg/m2 (≤16.0 kg/m2 or ≥40.0 kg/m2).
    6. The subject has serum LDL-C level > 4.94 mmol/L (190 mg/dL)
    7. The subject has current, or a history of significant gastrointestinal (GI) motility problems, including dysphagia or swallowing difficulty, or GI abnormalities such as chronic or severe constipation, sigmoid colitis, ulcers, or major GI surgery.
    8. The subject has biliary obstruction or proven liver dysfunction, i.e., cirrhosis, hepatorenal syndrome, or has liver function tests ≥3 times the normal values for at least 2 of the measurements (ALT, AST, alkaline phosphatase, and gamma-glutamyl-transferase).
    9. The subject is known to have a positive test for HIV 1 and 2 antibodies.
    10. The subject has a history of clinically severe lactose intolerance (the placebo tablets have a high lactose content) or hypersensitivity to previous exposure to MCI-196, as judged by the Investigator.
    11. The subject has a history of substance or alcohol abuse within the last year.
    12. The subject has a temporary catheter as a vascular access and is showing active signs of inflammation as a result of this which would significantly interfere with dialysis.
    13. The subject has participated in a clinical study with any experimental medication in the last 30, or an experimental biological product within the last 90 days, prior to signing of informed consent.
    14. The subject has had prior exposure to MCI-196 in the past 3 months.
    15. If on peritoneal dialysis, the subject has a recent history of peritonitis (within the previous 3 months).
    16. The subject is scheduled to receive a kidney transplant within the next 6 months.
    17. The subject has a history of rhabdomyolysis or myopathy.
    18. The subject is taking sevelamer (Renagel®), unless it can be safely stopped at Screening and an alternative phosphate binder prescribed (e.g. lanthanum, calcium-based phosphate binder), but only if deemed medically appropriate. If it is not appropriate to discontinue sevelamer, the subject should be excluded.
    19. The subject has hypersensitivity to simvastatin or any of its excipients (See Appendix 16.4 – SPC of Simvastatin)
    20. The subject is taking medicines which contraindicate the co-administration of simvastatin, specifically potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone), unless this can be safely discontinued at the Screening visit and for the duration of the study. Some additional medicines that should be used with caution with simvastatin are also excluded, namely cyclosporin, danazol, verapamil, amiodarone and grapefruit juice (>284mL daily), unless these too can be safely discontinued at the Screening visit and for the duration of the study.
    21. The subject has porphyria.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are the percentage change from Week 16 to Week 20 (or last observation carried forward (LOCF) post Week 16) in LDL-C for MCI-196 and placebo, and the non-inferiority of MCI-196 to simvastatin in percentage change from Week 0 to Week 16 (or last observation carried forward (LOCF) post Week 0) in LDL-C.
    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 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 Yes
    E.8.1.7.1Other trial design description
    withdrawal, double-dummy, flexible dose
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 240
    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 Decision2009-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-20
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