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    Summary
    EudraCT Number:2012-001348-24
    Sponsor's Protocol Code Number:3004
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-09-10
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-001348-24
    A.3Full title of the trial
    A pilot study of allopurinol to prevent GFR loss in type 1 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pilot study of allopurinol to prevent kidney function loss in type 1 diabetes
    A.3.2Name or abbreviated title of the trial where available
    pilot-PERL
    A.4.1Sponsor's protocol code number3004
    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 SponsorJoslin Diabetes Center
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJDRF
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJoslin Diabetes Center
    B.5.2Functional name of contact pointSection on Genetics and Epidemiolog
    B.5.3 Address:
    B.5.3.1Street Address1 Joslin place
    B.5.3.2Town/ cityBoston
    B.5.3.3Post code02215
    B.5.3.4CountryUnited States
    B.5.4Telephone number001617309-2406
    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 Allopurinol (Hexanurat)
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameHexanurat
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboCoated 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
    Type 1 diabetes, microalbuminuria or macroalbuminuria and mildly impaired kidney function.
    E.1.1.1Medical condition in easily understood language
    Type 1 diabetes and early signs of kidney complications
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To obtain estimates of the distribution of the primary outcome (GFR decline) in the study population in order to properly power a future pivotal clinical trial.

    E.2.2Secondary objectives of the trial
    2. To pilot study procedures, such as the run-in period, the allopurinol dosage adjustment algorithms, and the iohexol clearance GFR measurement.
    3. To gather preliminary data about the efficacy of allopurinol in reducing GFR decline over 2 years.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • • Male or female T1D patients between 18 and 60 years of age.
    • T1D diagnosed before age 35 and continuously treated with insulin within one year from diagnosis. If the onset was between ages 31 and 35, body mass index (BMI) will be required to be < 26 kg/m2 at the time of diagnosis;
    • Duration of T1D ≥ 5 years;
    • Presence of microalbuminuria or moderate macroalbuminuria (at least two out of three consecutive urinary albumin excretion rates [AER] or urinary albumin/creatinine ratios (ACR) measured during the preceding two years in the 30-1500 mg/24 hr or the 30-1500 mg/g range, respectively).
    • Estimated GFR (based on serum creatinine and the CKD-EPI equation) between 35 and 109 ml/min/1.73 m2 at the screening visit.
    • Measured GFR between 45 and 99 ml/min/1.73 m2 at the end of the run-in period;
    • Serum UA ≥ 4.5 mg/dl at the screening visit.
    • Willing to comply with schedule of events and protocol requirements.
    E.4Principal exclusion criteria
    • • History of gout requiring uric acid lowering therapy or xanthinuria or other indications for uric acid lowering therapy such as cancer chemotherapy or extremely high serum uric acid values (≥12 mg/dl)
    • Recurrent renal calculi.
    • Use of urate-lowering agents within 3 months before enrollment.
    • Current use of azathioprine, 6-mercaptopurine, didanosine, warfarin, tamoxifen, amoxicillin/ampicillin, or other drugs interacting with allopurinol.
    • Known allergy to xanthine-oxidase inhibitors or iodine containing substances.
    • HLA B*58:01 genotype (determined at the time of randomization) indicating increased risk of Stevens-Johnson syndrome in response to allopurinol.
    • Renal transplant.
    • Non-diabetic kidney disease as indicated by medical history and/or laboratory findings.
    • SBP>160 or DBP >100 mmHg at screening or SBP>140 or DBP>90 mmHg at the end of the run-in period.
    • Cancer treatment within two years before enrollment.
    • History of clinically significant hepatic disease including hepatitis B or C and/or ALT (SGPT) >2.50 x ULN at screening;
    • History of acquired immune deficiency syndrome or human immunodeficiency virus (HIV);
    • Hemoglobin concentration <11 g/dL (males), <10 g/dL (females) at screening.
    • Platelet count <100,000/mm3 at screening.
    • History of alcohol or drug abuse in the past 12 months
    • Breastfeeding or pregnancy or unwillingness to be on contraception.
    • Poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study.
    • Serious pre-existing medical problems other than diabetes, e.g. congestive heart failure, pulmonary insufficiency.
    E.5 End points
    E.5.1Primary end point(s)
    GFR at the end of the 2-year intervention measured by the plasma clearance of non-radioactive iohexol (iGFR) and adjusted for the GFR at baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 2 years study duration
    E.5.2Secondary end point(s)
    1. Estimated GFR (eGFR) time trajectory estimated from quarterly serum creatinine and cystatin C measurements using the CKD-EPI SCr and the CKD-EPI SCr-SCysC equations.
    2. Time to doubling of baseline serum creatinine value or ESRD (eGFR ≤ 15 ml/min/1.73 m2).
    3. Median urinary AER during the last three months of the intervention period, adjusted for the median urinary AER at baseline. Urinary AER will be determined in timed overnight urine collections brought by study participants to regular clinic visits, and expressed in g/minute and as urinary albumin creatinine ratios.
    4. Time to fatal or non-fatal cardiovascular events, defined as the composite of CVD death (ICD-10 code I10 to I74.9), myocardial infarction, stroke, coronary artery bypass grafting, or percutaneous coronary intervention.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the study
    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 Yes
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    United States
    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
    LVLS
    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 months2
    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 months2
    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: 30
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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)
    None
    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 Decision2012-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-07-07
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