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    Summary
    EudraCT Number:2010-020404-29
    Sponsor's Protocol Code Number:H9V-MC-GFRF
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-01-31
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-020404-29
    A.3Full title of the trial
    A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety and Renal Efficacy of LY2382770 in Patients with Diabetic Kidney Disease due to Type 1 or Type 2 Diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in Patients with Diabetic Kidney Disease
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberH9V-MC-GFRF
    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 SponsorEli Lilly and Company Limited, Indianapolis
    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 supportEli Lilly and Company Limited, Indianapolis
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly and Company
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameAnti-humanTGF-β1, subclass IgG4, humanized antibody LA307
    D.3.2Product code LY2382770
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.2Current sponsor codeLY2382770
    D.3.9.3Other descriptive nameAnti-humanTGF-β1, subclass IgG4, humanized antibody LA307
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) 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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Diabetic Kidney Disease due to Type 1 or Type 2 Diabetes
    E.1.1.1Medical condition in easily understood language
    Chronic kidney disease likely caused by diabetes
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    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
    Primary objective is to determine if LY2382770, administered monthly for 1 year is more effective than placebo at slowing the progression of diabetic kidney disease in patients treated with angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) administered monthly by subcutaneous injection for 1 year is more effective than placebo at slowing the progressive loss of kidney function, as measured by Serum Creatinine (SCr) change from baseline.
    E.2.2Secondary objectives of the trial
    To compare LY2382770 to placebo for:
    - safety and tolerability;
    - serum creatinine slope of change from baseline over time;
    - first morning urine protein/creatinine ratio change from baseline to endpoint;
    - Biomarkers related to efficacy
    To evaluate PK of LY2382770 and to determine within and between subject variability
    To explore population PK and PD relationships of LY2382770.
    To evaluate the frequency and clinical consequences of endogenous antibodies to LY2382770

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Two sub studies will be conducted:
    Genetic Sub study
    Because genetic variation may impact a patient’s response to therapy, study subjects will be asked to provide a 10-mL blood sample for potential pharmacogenetic analysis, unless collection
    is precluded by local regulations or ERB [IRB] policy. This is a one-time collection that can be collected at any study visit in randomized patients who consent to the collection, as noted in the
    Study Schedule (Protocol Attachment GFRF.1). Samples may be evaluated for association of genetic variants with diabetes and patient variance in response to LY2382770. Samples may be genotyped for genes that are believed to be related to safety
    associated with the mechanism of action of LY2382770.
    Samples will only be used for investigations related to the disease under study in this clinical trial, and the mechanism of action (including potential adverse effects) of LY2382770, and will
    not be used for broad exploratory genetic analysis.

    Storage samples sub study
    Blood (serum, plasma, and mRNA) and urine samples will be collected for potential nongenomic biomarker research unless collection is precluded by local regulations or ERB [IEC] policy. Protocol Attachment GFRF.1 specifies the times that blood and urine samples will be collected. Samples may be used for research related to LY2382770 activity, TGF-β signaling pathways and
    biological effects, and diabetes, DKD, and/or other associated comorbidities. Stored samples may also be used in validating assays related to these same research endeavors.
    E.3Principal inclusion criteria
    Men and women not of childbearing potential ≥25 years of age with type 1 or type 2 diabetes mellitus and either an SCr of 1.3 to 3.3 mg/dL (115 to 291 μmol/L) in women and 1.5 to 3.5 mg/dL (132 to 309 μmol/L) in men, or an estimated glomerular filtration rate (eGFR) of 20 to 60 mL/min/1.73m2, and a 24-hour urine PCR of ≥800 mg/g (≥91 mg/mmol), despite equilibration for ≥2 months on an appropriate dose of either ACEi or ARB therapy.
    E.4Principal exclusion criteria
    Chronic kidney disease (CKD) from causes other than presumed DKD, uncontrolled hypertension, unstable cardiovascular disease, cancer or predisposing conditions, autoimmune disease, chronic inflammatory disease, hepatitis B or C infection, cirrhosis or significant liver disease, systemic immunosuppression therapy, and recent gastrointestinal bleeding.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome Measures:
    Change in Serum Creatinine from baseline to 12 month endpoint [Time Frame: Baseline, 12 months].

    E.5.1.1Timepoint(s) of evaluation of this end point
    Serum Creatinine will be tested at:
    • Screening visit
    • Randomization visit (baseline) which can be done up to 4 weeks after the Screening visit
    • Visit 4 (8 weeks post baseline)
    • Visit 6 (17 weeks post baseline)
    • Visit 13 (34 weeks post baseline)
    • Visit 15 (43 weeks post baseline)
    • Visit 17 (51 weeks post baseline)
    • Visit 19 (64 weeks post baseline)
    E.5.2Secondary end point(s)
    Compare LY2382770 to placebo for:
    1- Safety and efficacy
    2 - First morning Urine Protein/Creatinine Ratio change from baseline to 12 month endpoint
    3 - biomarkers related to efficacy
    4 - Serum creatinine slope of change from baseline through 12 months
    Also:
    5 - Evaluation of PK properties of LY2382770
    6 - Explore PK and PD relationship of LY2382770
    7 - Evaluate the frequency and clinical consequences of endogenous antibodies to LY2382770
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - Safety and Efficacy
    AEs collected at all visits
    2 - First morning Urine Protein/Creatinine Ratio change from baseline to 12 month endpoint data collected at:
    - Screening visit
    - Visit 18
    3 - biomarkers related to efficacy
    Visits 2, 10 and 11
    4 - Serum creatinine slope of change from baseline through 12 months
    - Visit 1, 2, 4, 6, 13, 15, 17 and 19
    5 - Population PK (Attachment GFRF.4b.)
    - Visits 3, 4, 5, 7, 8, 9, 10, 11, 14, 16, 18
    6 - PD (as for #2 and #4 above) and PK as for #5 above. Detailed further in Protocol Schedule of Events
    7 - Antibodies
    Visits 1, 5, 11, 14 and 18
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial4
    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 concerned36
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Australia
    Czech Republic
    France
    Hungary
    Israel
    Puerto Rico
    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
    Provided in the protocol
    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 months0
    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 months5
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state88
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 207
    F.4.2.2In the whole clinical trial 400
    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)
    The study doctor can discuss alternative treaments or therpies with the subject. It is expected that standard of care will be continued for your disease.
    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 Decision2011-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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