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    Summary
    EudraCT Number:2005-004990-13
    Sponsor's Protocol Code Number:KRM-307
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-09-04
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2005-004990-13
    A.3Full title of the trial
    A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of
    Chronic Kidney Disease Progression in Patients with Moderate to Severe Chronic Kidney Disease
    including Assessment of Quality of Life
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    A.4.1Sponsor's protocol code numberKRM-307
    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 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 supportMitsubishi Tanabe Pharma Corporation
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNA
    B.5.2Functional name of contact pointNA
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryJapan
    B.5.4Telephone number000
    B.5.5Fax number000
    B.5.6E-mailnot@applicable.com
    B.Sponsor: 2
    B.1.1Name of SponsorKUREHA 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 supportKUREHA CORPORATION
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNA
    B.5.2Functional name of contact pointNA
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryJapan
    B.5.4Telephone number000
    B.5.5Fax number000
    B.5.6E-mailnot@applicable.com
    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 nameAST-120
    D.3.2Product code AST-120
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNN/A
    D.3.9.1CAS number 90597-58-3
    D.3.9.2Current sponsor codeAST-120
    D.3.9.3Other descriptive nameAST-120 Drug Substance, Spherical Carbon Adsorbent
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Moderate to Severe Chronic Kidney Disease
    E.1.1.1Medical condition in easily understood language
    NA
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    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 demonstrate AST-120, added to standard-of-care therapy in moderate to severe CKD, reduces the risk of progression of CKD as assessed by the development of a component of a triple composite endpoint (initiation of dialysis, kidney transplant, or doubling of sCr), when compared with placebo; and
    • To demonstrate the general safety and tolerability of long-term AST-120 therapy in CKD patients.
    E.2.2Secondary objectives of the trial
    Secondary objectives are as follows:
    • To evaluate the efficacy of AST-120 in reducing the risk of developing a component of a quadruple composite endpoint (initiation of dialysis, kidney transplant, doubling of sCr, or death) compared with placebo;
    • To evaluate the effects of AST-120 versus placebo, on other measures of renal function i.e. sCr, 24 hr urinary protein excretion, creatinine clearance, urea clearance, and 24 hr urinary creatinine excretion; and
    • To assess the effects of AST-120 versus placebo, on fat-soluble vitamin levels (A, D, E, and K), vitamin B-12, and folate levels.
    Exploratory objective of this study is;
    • To assess quality of life by KDQOL ™-36 questionnaire.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients that meet all of the following Inclusion Criteria may be enrolled into the study:
    1) Age 18 years or older;
    2) Moderate to severe CKD (in men: sCr ≥ 2.0 mg/dL[≥ 177 µmol/L] and ≤ 5.0 mg/dL[≤ 442 µmol/L]); in women: sCr ≥ 1.5 mg/dL[≥ 133 µmol/L] and ≤ 5.0 mg/dL[≤ 442 µmol/L]); , not anticipated to require dialysis or renal transplant within the next 6 months;
    3) Patient survival expected to be no less than one year;
    4) Serum creatinine in men ≥ 2.0 mg/dL [≥ 177 µmol/L] and ≤ 5.0 mg/dL [≤ 442 µmol/L] and in women ≥ 1.5 mg/dL [≥ 133 µmol/L] and ≤ 5.0 mg/dL [≤ 442 µmol/L] at the initial Screening visit;
    5) Proteinuria / Progressive deterioration in renal function:
    Urinary total protein to urinary total creatinine ratio (both values measured as mg/dL, or other like units) must be ≥ 0.5 on a spot void obtained at the Screening visit
    OR
    If the urinary total protein to urinary total creatinine ratio is <0.5, then the patient may return for a second Screening visit 3 months later. If the sCr value at the second Screening visit is >10% higher than the first Screening visit but not > 5.0 mg/dL [≤ 442 µmol/L] or if the urinary total protein to urinary total creatinine ratio is ≥ 0.5, then the patient may be enrolled (See Appendix E of the Protocol for a listing of qualifying sCr values based on initial and second Screening visit values).
    6) Sitting blood pressure ≤160/90 mmHg at both Screening and Baseline visits. In addition, blood pressure, if measured, must have been stable in hypertensive patients over the 3 months prior to Screening, with no more than 1 blood pressure reading > 160/90 mmHg;
    7) In patients being treated for hypertension, they should be on a stable anti-hypertensive regimen, defined as no changes in anti-hypertensive medications or doses in the last 3 months prior to the Baseline visit, and to include, a stable dose of either an ACEI or ARB unless contraindicated;
    8) Stable nutritional status; and
    9) Willingness to comply with the study and sign a written informed consent.
    E.4Principal exclusion criteria
    Patients that meet any of the following Exclusion Criteria must not be enrolled into the study:
    1) Obstructive or reversible cause of kidney disease;
    2) Nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine (both components measured as mg/dL or other like units) of > 6.0 as measured on a spot void;
    3) Adult polycystic kidney disease;
    4) History of previous kidney transplant;
    5) History of alcohol or drug abuse within the past 12 months;
    6) Known human immunodeficiency virus (HIV) infection;
    7) Received immunosuppressive therapy (including systemic corticosteroids for more than 5 days at a daily dose in excess of 0.1 mg/kg, prednisone equivalent) in the past 3 months, or anticipated to require such treatment during the study course;
    8) History of recent (within the past 6 months) accelerated or malignant hypertension;
    9) Patients who are likely to require changes in ACEI or ARB regimens during the course of this study;
    10) Uncontrolled arrhythmia or severe cardiac disease (New York Heart Association Class III - IV), including myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, cerebrovascular accident, or transient ischemic attack within the past 6 months;
    11) History of malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, or severe GI dysmotility, not attributable to the use of a phosphate binder;
    12) History of cancer within the past 5 years (cervical carcinoma in situ, low-grade cutaneous malignancy, or other low grade malignancy are exemptions);
    13) Alanine transaminase (ALT) or aspartate transaminase (AST) values > 2.5 times the upper limit of normal (ULN);
    14) Received any investigational agent or participated in a clinical study within the previous 3 months;
    15) Presence of any significant medical condition that might create an undue risk with study participation, or significantly confound the collection of safety and efficacy data in this study; or
    16) For women of childbearing potential, a positive pregnancy test result of serum beta human chorionic gonadotropin (βHCG) or unwillingness to use approved single barrier or oral contraception, or unwillingness to be sexually abstinent.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the occurrence of one component of a triple
    composite of renal outcomes: initiation of dialysis, kidney transplantation,
    or doubling of sCr from the value obtained at the Baseline visit (Visit 2).
    The initial doubled (from Baseline) sCr result will be verified 5-10 days
    later with another sCr sampling. If this result remains doubled, a
    confirmatory measurement of sCr doubling will occur at 4-6 weeks after
    the initial doubled result was reported. If the Baseline value is not
    available for comparison, the value obtained at the Screening visit (Visit 1)
    will be used, If a second screening visit is performed then that screening
    value will be used. An Endpoint Adjudication Committee (EAC) will review
    and adjudicate all potential endpoint events.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    E.5.2Secondary end point(s)
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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.8.2.4Number 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    European Union
    Argentina
    Brazil
    Canada
    Mexico
    Russian Federation
    Ukraine
    United States
    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
    When 291 renal outcome events have occured and met the criteria for an adjudicated study event, the study will be considered completed.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 980
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 980
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 153
    F.4.2.2In the whole clinical trial 980
    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)
    Subjects will revert to standard care after his/her participation in the trial has ended
    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 Decision2007-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-22
    P. End of Trial
    P.End of Trial StatusCompleted
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