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    Summary
    EudraCT Number:2005-002095-15
    Sponsor's Protocol Code Number:KRX-101-401
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-08-22
    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 ConcernedUK - MHRA
    A.2EudraCT number2005-002095-15
    A.3Full title of the trial
    The Collaborative Study Group Trial: The Effect of Sulodexide in Overt Type 2 Diabetic Nephropathy
    A.3.2Name or abbreviated title of the trial where available
    Sulodexide in Overt Type 2 Diabetic Nephropathy
    A.4.1Sponsor's protocol code numberKRX-101-401
    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.3.10 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
    Overt Type 2 Diabetic Nephropathy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10061835
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether sulodexide, compared to placebo, increases the time to the first occurrence of the composite end point of doubling of the serum creatinine from baseline, or end-stage renal disease (ESRD) in patients with diabetic nephropathy due to type 2 diabetes; and to compare the safety and tolerance of sulodexide with placebo when administered long-term to patients with diabetic nephropathy due to type 2 diabetes.
    E.2.2Secondary objectives of the trial
    To determine whether sulodexide, compared to placebo: decreases the incidence rate of the composite endpoint of a doubling of the serum creatinine from baseline or ESRD in patients with diabetic nephropathy due to type 2 diabetes, increases the time to the individual outcomes of a doubling of the serum creatinine from baseline and ESRD in patients with diabetic nephropathy due to type 2 diabetes, decreases the incidence rates of the individual outcomes of a doubling of the serum creatinine from baseline and ESRD in patients with diabetic nephropathy due to type 2 diabetes, decreases urinary protein excretion as measured by protein creatinine ratio (PCR) and albumin creatinine ratio (ACR) in patients with diabetic nephropathy due to type 2 diabetes, and changes all-cause mortality.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Males and non-lactating and non-pregnant females. Females must be post-menopausal, surgically sterile, or using adequate contraception. All women of child-bearing potential must have a negative serum pregnancy test (minimum sensitivity 25 IU/L of β-HCG) at Visit 1 and within 72 hours prior to the start of study medication;

    2. Diagnosis of type 2 diabetes (see Appendix C);

    3. Age equal or more than 18 years old. Upper age limit is at the discretion of the investigator and should be based on the judgment of the investigator that the patient is likely to survive at least 2 years;

    4. Total protein from a 24-hour urine collection at Visit 2 is equal or more than 900 mg/24 hr (equal or more than 0.9 G/24 hr);

    5. Serum creatinine in women between 1.3 and 3.0 mg/dL (115-265 μmol/L), inclusive, and in men between 1.5 and 3.0 mg/dL (133-265 μmol/L), inclusive, at Visit 1. If the screening serum creatinine falls outside the specified creatinine criteria, a patient may enter the Run-in Period if the GFR by the MDRD formula at Visit 1 is between 25 to 45mL/min;

    6. Willing to discontinue antihypertensive medication regimen, if applicable; and

    7. Willing and able to give informed consent.
    E.4Principal exclusion criteria
    1. Type 1 (insulin-dependent; juvenile onset) diabetes;

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

    3. Patients who are taking antiplatelet or anticoagulant agents (with the exception of aspirin <100 mg/day);

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

    5. Patients who require ACEI, but not ACEI/ARB combination, may enter the trial if approved by the Clinical Coordinating Center;

    6. Cardiovascular disease as follows:
    • Unstable angina pectoris within 3 months of study entry;
    • Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months of study entry;
    • Transient ischemic attack within 3 months of study entry;
    • Cerebrovascular accident within 3 months of study entry;
    • New York Heart Association Functional Class III or IV (Note: if a patient is New York Heart Association Functional Class I or II and requires an ACEI, consult with the Clinical Coordinating Center to obtain permission for the patient to be on an ACEI rather than an ARB);
    • Obstructive valvular heart disease or hypertrophic cardiomyopathy; or
    • Second or third degree atrioventricular block not successfully treated with a pacemaker;

    7. Need for chronic (>2 weeks) immunosuppressive therapy, including corticosteroids (excluding inhaled or nasal steroids);
    8. New diagnosis of cancer or recurrent cancer within 5 years of screening (except non-melanoma skin cancer);
    9. Psychiatric disorder that interferes with the patient’s ability to comply with the protocol;
    10. Inability to tolerate oral medication or a history of significant malabsorption;
    11. History of alcohol or other drug abuse within 12 months of study entry;
    12. Known human immunodeficiency virus disease;
    13. Any other medical condition which renders the patient unable to or unlikely to complete the study, or which would interfere with optimal participation in the study or produce significant risk to the patient;
    14. Receipt of any investigational drugs (including placebo) within 30 days of enrollment;
    15. Evidence of hepatic dysfunction including total bilirubin >2.0 mg/dL (>35 mol/L) or liver transaminase (aspartate aminotransferase [AST] or alanine transferase [ALT]) >3 times upper limit of normal at Screening;
    16. Anticipate need for surgery;
    17. Inability to cooperate with study personnel or history of noncompliance to medical regimen, (i.e., patients who would be expected to comply poorly with treatment);
    18. Known allergies or intolerance to any heparin-like compound including heparin-induced thrombocytopenia Type II;
    19. Prior exposure to sulodexide, either in a clinical setting or as a participant in another clinical study.
    20. Untreated urinary tract infection that would impact urinary protein values.
    E.5 End points
    E.5.1Primary end point(s)
    This is a maximal event trial that has been designed to enroll approximately 2240 patients and to follow these patients until approximately 500 composite endpoints have occurred or the DSMC recommends the trial be closed due to either efficacy or futility. The primary hypothesis is to test whether sulodexide (200 mg) as compared to placebo will significantly increase the time to the first occurrence of the composite endpoint of a doubling of the serum creatinine from baseline or ESRD in patients with diabetic nephropathy due to type 2 diabetes.
    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.8.4.1Number of sites anticipated in Member State concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA125
    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 end-of-trial (completion) date is when all patients have completed all study visits or have otherwise discontinued from the study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 2240
    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 Decision2005-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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