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    Summary
    EudraCT Number:2004-000673-57
    Sponsor's Protocol Code Number:PRO-RENAL-REG-063
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-10-19
    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 ConcernedAustria - BASG
    A.2EudraCT number2004-000673-57
    A.3Full title of the trial
    Efficacy and Safety of Epoetin-Omega i.v. for Treatment of Anemia in Hemodialyzed Patients Hyporesponsive to a Previous Epoetin Beta i.v. Treatment: a Randomized, Parallel Group Trial.
    A.3.2Name or abbreviated title of the trial where available
    Epomax Hyporesponsive patients study
    A.4.1Sponsor's protocol code numberPRO-RENAL-REG-063
    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 SponsorBaxter Healthcare S.A.
    B.1.3.4CountrySwitzerland
    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 Information not present in EudraCT
    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 nameEPOMAX 16000 IU, solution for injection
    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
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepoetin omega
    D.3.9.2Current sponsor coderHu-EPO
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16000
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 typemedicinal product developped by means of recombinant DNA technology (as per the Annex to Council Regulation 2309/93)
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Information not present in EudraCT
    D.2.1.1.1Trade name NeoRecormon Multidose 50,000IU Powder and solvent for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameNEORECORMON
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepoetin beta
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 typemedicinal product developped by means of recombinant DNA technology (as per the Annex to Council Regulation 2309/93)
    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 End Stage Renal Disease (ESRD) Hemodialyzed Patients Hyporesponsive to a Previous Epoetin Beta i.v. Treatment
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10009120
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is an exploratory trial aimed at evaluating the hypothesis that dialyzed anemic patients hyporesponsive to intravenous Epoetin Beta treatment would benefit from “switching” the treatment to intravenous Epoetin Omega.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Potential candidates for enrolment will be selected based on a detailed medical history Chart Review. In addition, the potential patients, who have provided written consent, will then undergo a screening visit evaluation in order to confirm their eligibility for inclusion in the study.
    In order for a patient to be considered as a potential candidate for enrolment, the following conditions must be verified by objective evidence during the Chart Review

    Inclusion Criteria:
    1. Patients have been adequately selected by the Chart Review.
    2. Patients have provided written and signed informed consent.
    3. Hb at the screening visit <11.0 g/dl.
    4. Total Epoetin Beta dose delivered in the week between screening and day 1 visit is ≥200 IU/kg.
    5. Delivered Kt/V >1.20 at the screening visit (renal clearance to be added to K in case of RRF (urine volume >100ml and renal urea clearance >0.5ml/min). In the case that the Kt/V determination is not possible, a URR of >65% at the screening visit will be accepted.
    6. Patients with an adequate iron status defined as TSAT ≥20% and ferritin ≥100µgl at the screening visit.
    E.4Principal exclusion criteria
    1. Patients with a history of a hypertensive crisis within 8 weeks prior to the screening visit.
    2. Patients with aluminium overload, defined as serum Al >60 µg/l (or 2.22 µmol/l) at the screening visit.
    3. Patients with vitamin B12 deficiency (<200ng/l) or folic acid deficiency (<3.0µg/l) at the screening visit.
    4. Patients suffering from cancer that cannot be considered as “in remission”.
    5. Patients whose life expectancy in the judgment of their physician is 6 months or less.
    6. Patients with hemolytic anemia or anemia due to diseases other than ESRD (e.g., hemoglobinopathies, myelodisplasia etc.).7. Patients who have experienced a clinically relevant blood loss or hemolysis within 4 weeks prior to the screening visit.
    8. Patients with known epilepsy.
    9. Patients with hyperparathyroidism who have:
    • Verified osteitis fibrosa and/or indication for parathyroidectomy
    • iPTH >500 pg/ml at the screening visit and have not been treated for hyperparathyroidism
    • Undergone parathyroidectomy within 6 weeks prior to the screening visit
    10. Pregnant or lactating patients.
    NB: Female patients of childbearing potential must have a negative serum (or urine if appropriate) pregnancy test at the time of screening and will be required to use a medically acceptable means of contraception during their participation in the study. Women of childbearing potential are defined as women less than 55 years old who have not had a partial or full hysterectomy.
    11. Patients with an acute infection / inflammation or an exacerbation of a chronic disease.
    12. Patients with HIV.
    13. Patients that received erythropoiesis stimulators (other than Epoetin Beta), such as androgens, cytotoxic agents, radiation treatment, high-dose immunosuppressants, interferon or ribavirin within 12 weeks prior to screening. Low-dose immunosuppressants, interferon, ribavirin and similar therapeutic agents that are used on chronic basis for the control of a chronic disease are acceptable.
    14. Patients participating in another interventional study.
    15. Patients who have received an investigational drug within 30 days prior to the screening visit.
    16. Patients with known hypersensitivity to erythropietin or mammalian cell line products or human serum albumin.
    17. Patients with a history of acquired pure red cell aplasia (PRCA) of any cause.
    18. Patients with serum albumin < 30 g/l at the screening visit.
    19. Patients with a history of anti-erythropoietin antibodies.
    20. Patients scheduled for living donor renal transplant or other elective surgery within the next 6 months.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Variables:
    1. Average weekly dose (IU/kg) delivered in weeks 13-16.
    2. Average Hb (g/dl) in weeks 13-16.
    3. Average Erythropoietin Resistance Index (ERI) in weeks 13-16.
    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 Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Visit 16 (Week 16) is the end of study visit .
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 Information not present in EudraCT
    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 2004-10-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 46
    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 Decision2004-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
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