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    Summary
    EudraCT Number:2008-003458-13
    Sponsor's Protocol Code Number:AFX01_201
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-25
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-003458-13
    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 Peritoneal Dialysis Subjects Previously Treated With Epoetin
    A.4.1Sponsor's protocol code numberAFX01_201
    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 Global Research & Development Centre (Europe) 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.3.2Product code AF37702
    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.3.9.2Current sponsor codeAF37702
    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 typesmall molecule
    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 10058116
    E.1.2Term Nephrogenic anaemia
    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 of this study is:
    • To demonstrate that AF37702 Injection can maintain hemoglobin (Hgb) levels in peritoneal dialysis subjects following conversion from epoetin (alfa or beta).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To determine the proportion of subjects who have a Hgb target of 10 to 12 g/dL following conversion from epoetin (alfa or beta) to AF37702 Injection.
    • Evaluate the safety profile of AF37702 Injection in peritoneal dialysis subjects who were previously receiving epoetin (alfa or beta).

    The exploratory objective of this study is:
    • To evaluate change from Baseline in patient-reported outcomes (PRO) assessment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility is determined according to the following criteria:
    1. 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 authorised representative (if appropriate) signs a written, informed consent form prior to the initiation of any study procedures.
    4. A female subject of childbearing potential who is sexually active agrees to routinely use acceptable contraception from Screening throughout the duration of the study.
    5. The subject has chronic renal failure and has been on peritoneal dialysis for ≥3 months prior to enrollment.
    6. The subject is on stable SC epoetin (alfa or beta) maintenance therapy 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 4 weeks prior to enrollment.
    7. The subject has 4 consecutive Hgb values with a mean ≥10.0 and ≤12.0 g/dL during the Screening Period, with the difference between the mean of the first 2 consecutive Hgb values and the mean of the last 2 consecutive Hgb values being ≤1.0 g/dL. Qualifying Hgb values must be taken 2 or more days between Hgb values with a maximum of 2 Hgb with one calendar week and 9 or more days between the first and the last of the 4 qualifying Hgb values. (Note: a maximum of 6 Hbg values may be obtained during a screening effort).
    8. The subject has 1 ferritin level ≥100 ng/mL within 4 weeks prior to enrollment.
    9. The subject has 1 serum folate level ≥ lower limit of normal within 4 weeks prior to enrollment.
    10. The subject has 1 vitamin B12 level ≥ lower limit of normal within 4 weeks prior to enrollment.
    11. The subject has a negative test result for hepatitis B surface antigen, and hepatitis C virus antibody at Screening and no known history of human immunodeficiency virus infection.
    E.4Principal exclusion criteria
    Any subject who meets any of the following criteria will not qualify for entry into the study:
    1. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 1 month after end of dosing this study; or intending to donate ova during such time period.
    2. The subject has known intolerance to any erythropoiesis-stimulating agent, all parenteral iron supplementation products, or any PEGylated molecules.
    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, pure red cell aplasia [PRCA], homozygous sickle-cell disease, thalassemia, multiple myeloma, hemolytic anemia and myelodysplastic
    syndrome).
    5. The subject has had red blood cell (RBC) or whole blood transfusion within 12 weeks prior to enrollment.
    6. The subject has received a recent course of intensive iron replacement (ie, has received more than 500 mg IV (intravenous) in the 28 days prior to enrollment).
    7. The subject has poorly controlled hypertension within 4 weeks prior to enrollment, per investigator’s clinical judgment.
    8. The subject has advanced chronic congestive heart failure – New York Heart Association Class III or IV.
    9. The subject has uncontrolled, or symptomatic inflammatory disease (eg, rheumatoid arthritis, systemic lupus erythematosus, etc).
    10. The subject has a known history of seizure disorder or received anti-epileptic medication for seizure disorder within 6 months prior to enrollment.
    11. The subject has a history of peritonitis within the 2 months prior to enrollment.
    12. The subject has any clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent.
    13. The subject has evidence of active malignancy within past 5 years (except nonmelanoma skin cancer or carcinoma-in-situ that has been completely excised).
    14. The subject has a scheduled kidney transplant (Note: subjects currently on a transplant wait list are not excluded unless there is an identified donor).
    15. The subject is anticipated to change dialysis modality during the course of the study.
    16. The subject has a scheduled surgery that may be expected to lead to significant blood loss.
    17. The subject has previous exposure to any investigational agent within 4 weeks prior to enrollment, or planned
    receipt of an investigational agent, other than as specified by this protocol, during the study period.
    18. The subject has previous exposure to AF37702 Injection.
    19. The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to enrollment.
    20. The subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, or sibling) of a study site employee, involved in conduct of this study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint
    Mean change in Hgb between Baseline (the mean of the 4 most recent Hgb values prior to enrollment plus the Hgb value on the day of enrollment) and the evaluation period (mean Hgb from weeks 20 to 25).

    Secondary Efficacy Endpoints
    • Proportion of subjects who have mean Hgb values within the target range of 10.0 to 12.0 g/dL during the evaluation period.
    • Proportion of subjects with a change in Hgb between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment plus the Hgb value on the day of enrollment) and the evaluation period (mean Hgb from weeks 20 to 25) of ≤ ± 1 g/dL.
    • Proportion of subjects who receive RBC transfusions during the Titration Period and the Evaluation Period.
    • Mean Hgb during 4-week intervals (weeks 1-4, 5-8, etc)until completion of the evaluation phase of the study.
    • Proportion of subjects who maintain a target Hgb of 10.0 to 12.0 g/dL during 4-week intervals (weeks 1-4, 5-8, etc) until completion of the evaluation phase of the study.
    • Proportion of subjects requiring dose adjustments during the study.
    • Safety Endpoint:
    – Adverse events (AEs) and serious adverse events (SAEs).
    – Physical examination (including dry weight, vital signs, and oral temperature).
    – Clinical laboratory tests.
    – Composite safety endpoint.
    – Proportion of subjects with confirmed (2 consecutive values) Hgb outside the range of 10.0 to 12.0 g/dL.
    – Proportion of subjects with confirmed (2 consecutive values) Hgb values ≥12.0 g/dL, ≥13.0 g/dL, and ≥14.0 g/dL.
    – Proportion of subjects with Hgb increases of >1.0 g/dL in any 2-week interval during the Titration and Evaluation periods.
    – Proportion of subjects with Hgb increases of >2.0 g/dL in any 4-week interval during the Titration and Evaluation periods.
    – Incidence of AF37702-specific antibody formation.

    Exploratory Endpoint:
    • Change from Baseline in the following PRO: EQ-5D, and Kidney Disease Quality of Life (KDQoL) Short Form v.1.2™
    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 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 Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned10
    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 years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    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.1.3Elderly (>=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 2008-07-25. 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    under going peritoneal dialysis
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 60
    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 Decision2008-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-19
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