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    Summary
    EudraCT Number:2005-003158-91
    Sponsor's Protocol Code Number:KRX-101-301
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-08-24
    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 number2005-003158-91
    A.3Full title of the trial
    THE COLLABORATIVE STUDY GROUP TRIAL:
    THE EFFECT OF SULODEXIDE IN PATIENTS WITH TYPE 2 DIABETES
    AND MICROALBUMINURIA
    A.3.2Name or abbreviated title of the trial where available
    Sulodexide in Type 2 Diabetes with Microalbuminuria
    A.4.1Sponsor's protocol code numberKRX-101-301
    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 SponsorKeryx Biopharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 Information not present in EudraCT
    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 nameSulodexide
    D.3.2Product code KRX-101
    D.3.4Pharmaceutical form Capsule, soft
    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 INNSulodexide
    D.3.9.1CAS number 57821-29-1
    D.3.9.2Current sponsor codeKRX-101
    D.3.9.3Other descriptive nameSulodexide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeproduct is extracted from crude heparin
    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, soft
    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
    Type 2 Diabetic Microalbuminuria
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10027525
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to determine the safety and efficacy of sulodexide in the treatment of patients with type 2 diabetes and persistent microalbuminuria, despite being treated with a maximum approved dose of an angiotensin II receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEI).

    The primary efficacy measure will be the percentage of patients achieving “therapeutic success,” which is defined as a composite binary endpoint of conversion from microalbuminuria to normoalbuminuria (ACR <25 mg/G [2.8 mg/mmol] for men and ACR <35 mg/G [4.0 mg/mmol] for women) and at least a 25% reduction in ACR level relative to baseline at Week 26 or a >50% reduction in ACR level relative to baseline at Week 26.

    E.2.2Secondary objectives of the trial
    The secondary efficacy measures will include:
    1) percentage of patients achieving normoalbuminuria at Weeks 8, 16, and 26 on therapy, and at Weeks 30 and 34 (4 and 8 weeks off therapy, respectively);
    2) percentage of patients achieving >50% reduction in ACR from baseline at Weeks 8, 16, and 26 on therapy, and at Weeks 30 and 34 (4 and 8 weeks off therapy, respectively);
    3) observed ACR, and change from baseline in ACR at Weeks 8, 16, and 26 on therapy, and at Weeks 30 and 34 (4 and 8 weeks off therapy, respectively);
    4) percentage of patients reaching an ACR 200 mg/G (22.6 mg/mmol) at Weeks 8, 16, and 26 on therapy, and at Weeks 30 and 34 (4 and 8 weeks off therapy, respectively); and
    5) percentage change from baseline on various additional endpoints, including serum creatinine, Modification of Diet in Renal Disease (MDRD) estimated glomerular filtration rate (GFR), and serum albumin.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    The principle inclusion criteria for the study includes men and women with type 2 diabetes and persistent microalbuminuria (in men urine albumin creatinine ratio [ACR] 35 – 200 mg albumin/G creatinine [4.0 - 22.6 mg/mmol], in women urine ACR 45 – 200 mg albumin/G creatinine [5.1 – 22.6 mg/mmol] based on the geometric mean of 3 first voided AM urine samples at the qualifying visit [Visit 6]). Patient’s serum creatinine must be 1.5 mg/dL at screening.
    E.4Principal exclusion criteria
    1. Age of onset of type 2 diabetes <18 years;

    2. HbA1C >10.0%;

    3. Morbid obesity defined as a body mass index (BMI) 45 kg/m2;

    4. Type 1 (insulin-dependent; juvenile onset) diabetes;

    5. Renal disease as follows:
    Patients with known non-diabetic renal disease (nephrosclerosis superimposed on diabetic nephropathy acceptable);
    Renal allograft;

    6. Absolute requirement for combination therapy of ACEI and ARB;

    7. Known allergies or intolerance to any heparin-like compound;

    8. Untreated urinary tract infection that would impact urinary protein values; or

    9. Prior exposure to sulodexide, either in a clinical setting or as a participant in another clinical study.
    E.5 End points
    E.5.1Primary end point(s)
    Patients assigned to sulodexide 200 mg will achieve a significantly higher fraction of patients with “therapeutic success” at Week 26, as defined by the composite binary endpoint of conversion from microalbuminuria to normoalbuminuria (ACR <25 mg/G [2.8 mg/mmol] for men and ACR <35 mg/G [4.0 mg/mmol] for women) and at least a 25% reduction in ACR level relative to baseline at Week 26 or a >50% reduction in ACR level relative to baseline at Week 26.
    The primary efficacy analysis will be implemented by Fisher’s exact test.
    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 Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    The study will terminate after all patients are randomized and have been in the study through the end of the Washout Period.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 1000
    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)
    Patients are returned to the care of their primary physicians for treatment of their condition as deemed appropriate by that physician.
    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 Decision2005-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-02-28
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