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    Summary
    EudraCT Number:2008-003459-64
    Sponsor's Protocol Code Number:AFX01-202
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-12-29
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2008-003459-64
    A.3Full title of the trial
    A Phase 2 Study of the Safety and Efficacy of AF37702 Injection for the Maintenance Treatment of Anemia in Subjects with Chronic Renal Failure Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa
    A.3.2Name or abbreviated title of the trial where available
    AFX01-202
    A.4.1Sponsor's protocol code numberAFX01-202
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorTAKEDA EUROPE RESEARCH & DEVELOPMENT CENTRE LTD
    B.1.3.4CountryUnited Kingdom
    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 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 nameAF37702 injection
    D.3.2Product code AFX01
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 913976-27-9
    D.3.9.2Current sponsor codeAF377202 injection
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) 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 No
    D.3.11.8Extractive medicinal product No
    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 typePeptide Sintetico
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ANAEMIA
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10002045
    E.1.2Term Anaemia haemolytic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective ofthis study is: To demonstrate that AF37702 Injection can maintain hemoglobin (Hgb) in chronic renal failure subjects on hemodialysis and not yet on dialysis following conversion from darbepoetin alfa.
    E.2.2Secondary objectives of the trial
    The secondary objectives ofthis study are: To determine the proportion of subjects who maintain a Hgb target of 10-12 g/dl, following conversion from darbepoetin alfa to AF37702 Injection. Evaluate the safety profile of AF37702 Injection in chronic renal failure subjects on hernodialysis and not yet on dialysis who were previously recei ving darbepoetin alfa. The exploratory objective of this study is: To evaluate change from haseline in patient-reported outcomes (PRO) assessment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main Criteria for lnclusion: Subject eligibility is determined according to the following criteria: l. The subject is male or female and aged 18 to 90 years, inclusive. 2. The subject is capable of understanding and complying with protocol requirements. 3. The subject or the subject`s legally authorized representative, (if appropriate), signs a written, informed consent form prior to the initiation of any study procedures. 4. A female subject of childbearing potenti al who is sexually active agrees to use adequate contraception (as defined in the informed consent form) from screening throughout the duration ofthe study. 5. The subject has chronic renal failure and meets one of the following criteria: a) Has been on hemodialysis for z6 months prior to enrollment. b) Has not yet begun dialysis (hemodialysis or peritoneal dialysis) and is not anticipated to transition to dialysis during participation in the study. 6. The subject is on stable darbepoetin alfa maintenance therapy (either SC or IV) continuously prescribed for a minimum of 8 weeks prior to enrollment. Stability is defined as :::;50%change from the maximum prescribed weekly dose (ie, [max-min]/max :::;0.5)with no change in prescribed frequency during the last 4 weeks prior to enrollment. 7. The subject has 4 consecutive Hgb values with a mean zlO.O and :0;12.0g/dL during the Screening Period, with the difference between the mean of the first 2 consecuti ve Hgb values and the mean of the last 2 consecuti ve values being :0;1.0gldL. Qualifying Hgb values must be taken2 or more days between Hgb values, with maximum of2 Hgb values within one calcndar week and 9 or more days between the first and last ofthe 4 qualifying Hgb values. (Note: a maximum of 6 Hgb values may be obtained during a screening effort). 8. The subject has I ferritin leve! z 100 nglmL within 4 weeks prior to enrollment. 9. The subject has l serum or red cell folate level z lower limit ofnormal within 4 weeks prior to enrollment. lO. The subject has l vitamin B 12 level z lower limit of normal within 4 weeks prior to enrollment. Il. The subject has a negati ve test refult for hepatitis B surface antigen, and hepatitis C virus antibody at Screening and no knOWJ1history ofhuman immunodeficiency virus infection.
    E.4Principal exclusion criteria
    Main Criteria for Exclusion: Any subject who meets any ofthe following criteria will not qualify for entry into the study: l. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 28 days after the end of this study; or intending to donate ova during such time period. 2. The subject has known intolerance to any ESA, all parenteral iron supplementation products, or any PEGylated molecule. 3. The subject has known bleeding or coagulation disorder. 4. The subject has known hematologic disease or cause of anemia other than renal disease (eg, PRCA, homozygous sickle-cell disease, thalassemia, multiple myeloma, hemolytic anemia and myelodysplastic syndrome). 5. The subject has had RBC or whole blood transfusion within 12 weeks prior to enrollment. 6. The subject has received a recent course ofintensive iron replacement (ie, has received more than 500 mg IV in the 28 days prior to enrollment). 7. The subject has poorly controlled hypertension witlu`n4 weeks prior to enrollment, per investigator`s clinical judgment.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint Mean change in hemoglobin between Baseline (the mean ofthe four most recent hemoglobin values prior to enrollment and the Hgb on the day ofenrollment) and the evaluation period (mean Hgb from wks 19 to 24).
    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 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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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 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.1.3Elderly (>=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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-12-29. Yes
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 100
    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 Decision2009-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-12-24
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