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    Summary
    EudraCT Number:2005-002218-39
    Sponsor's Protocol Code Number:AFX01-04
    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:2005-06-28
    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 number2005-002218-39
    A.3Full title of the trial
    A Phase 2, Open-label, Multi-center, Sequential Dose Finding Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Multiple Doses of AF37702 Injection (HematideTM) in Chronic Kidney Disease Patients Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment
    A.3.2Name or abbreviated title of the trial where available
    AFX01-04
    A.4.1Sponsor's protocol code numberAFX01-04
    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 SponsorAffymax, 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 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 AF37702, Hematide
    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 IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet received
    D.3.9.1CAS number Not given
    D.3.9.2Current sponsor codeAF37702
    D.3.9.3Other descriptive nameHematide
    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 No
    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 in patients with chronic kidney disease not on dialysis (pre-dialysis patients).
    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
    To determine the range of monthly (i.e., Q4W, every 4 weeks) doses of AF37702 Injection administered subcutaneously that increases and maintains hemoglobin at 11-13 g/dL in Chronic Kidney Disease (CKD) patients not on dialysis (pre-dialysis patients).
    E.2.2Secondary objectives of the trial
    To evaluate the safety profile of up to six doses of AF37702 Injection administered subcutaneously on a Q4W schedule in pre-dialysis patients.

    To evaluate the pharmacokinetic profiles of up to six doses of AF37702 Injection administered subcutaneously on a Q4W schedule in pre-dialysis patients (in a subset of study patients).

    To evaluate the safety and pharmacodynamic profiles of up to six doses of AF37702 Injection administered intravenously on a Q4W schedule in pre-dialysis patients, with pharmacokinetic profiles in a subset of these patients.

    To evaluate the safety and pharmacodynamic profiles of AF37702 Injection administered subcutaneously once every two weeks (Q2W) for up to 12 doses, with pharmacokinetic profiles in a subset of these patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject has signed a written, witnessed informed consent. Males or females, including women of childbearing potential on a highly effective method of birth control, age 18 - 85 years. GFR of ≤ 60 mL/min. Hemoglobin ≥ 9.0 and < 11.0 g/dL, serum ferritin ≥100 μg/L and transferrin saturation ≥ 20%, serum or red cell folate and vitamin B12 levels above the lower limits of normal, weight ≥ 45 kg, WBC ≥ 3.0 x10^9/L, platelet count ≥ 100 x10^9/L.
    E.4Principal exclusion criteria
    Any previous exposure to investigational or commercially available erythropoiesis stimulating agents (ESAs) in the 12 weeks prior to study enrollment, prior treatment with Eprex, intolerance of any ESA. History of PRCA. RBC transfusion within 12 weeks. Hemoglobinopathy, hemolysis, inflammatory disease, CRP > 30 mg/L, significant infection, febrile illness, hyperparathyroidism, poorly controlled hypertension, epileptic seizures, CHF (NYHA Class IV). Significant medical diseases or conditions, including history of MI, coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric or neurological abnormalities, liver disease, active HIV disease, significant history of multiple drug allergies, or other diseases within the past 6 months that may interfere with patient assessment. Malignancy within past 5 years, life-expectancy < 12 months, anticipated elective surgery, previous exposure to any investigational drug within prior 6 weeks or expected during the study.
    E.5 End points
    E.5.1Primary end point(s)
    Hemoglobin change from baseline at weekly intervals through Week 13 and at 2-week intervals through Week 25 • Proportion of patients per cohort with hemoglobin within 11-13 g/dL at Weeks 9, 13, 17, 21, and 25 • Proportion of patients per cohort achieving a Hgb response, defined as a Hgb increase of ≥ 1.0 g/dL from baseline and a Hgb ≥ 11.0 g/dL during the study • Number (%) of patients with no dose adjustments during the study and number (%) of patients with dose increase or decrease during the study • Incidence of red blood cell transfusions during the study • Pharmacologic parameters including RBCs, hematocrit, reticulocyte counts, reticulocyte hemoglobin content, and serum measures of iron status (e.g., serum ferritin, transferrin saturation, and transferrin receptor protein) • Adverse events (AEs) • Serious adverse events (SAEs) • Pharmacokinetic parameters including Cmax, AUC0-t, AUC0-∞, t½ß, Vd, Vss, and CL (in a subset of patients)
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 No
    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) No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    The end of the trial is defined as 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 years2
    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 years2
    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 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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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 Decision2005-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-11-08
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