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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-003302-28
    Sponsor's Protocol Code Number:ERYTH 03/05
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-08-30
    Trial 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 ConcernedLithuania - SMCA
    A.2EudraCT number2005-003302-28
    A.3Full title of the trial
    “MAINTENANCE PHASE STUDY”
    A THERAPEUTIC EQUIVALENCE STUDY COMPARING THE EFFICACY AND SAFETY OF INTRAVENOUS EPOETIN (PLIVA) AND EPOETIN ALFA (JANSSEN CILAG) IN PATIENTS WITH CHRONIC RENAL FAILURE REQUIRING HEMODIALYSIS AND RECEIVING EPOETIN MAINTENANCE TREATMENT
    A multinational, multicenter, randomized, comparator controlled, parallel-group, double blind phase III study
    A.4.1Sponsor's protocol code numberERYTH 03/05
    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 SponsorPLIVA Research and Development Ltd.
    B.1.3.4CountryCroatia
    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 nameEpoietin (Pliva)
    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.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 typeHormone
    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 EPREX
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Ltd., Saunderton
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEPREX (Epoietin alfa)
    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.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 typeHormone
    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
    Chronic renal failure induces a progressive decline of the kidney function that leads to end stage renal disease (ESRD). The end stage is reached when the glomerular filtration rate decreases to < 5 mL/minute. In patients with chronic renal failure the production of hormones such as erythropoietin is disturbed. Anemia is present in the majority of patients with chronic renal failure. This anemia is usually caused by erythropoietin deficiency (although other factors can contribute)
    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 demonstrate equivalent efficacy of epoetin (PLIVA) compared to epoetin alfa (Janssen Cilag), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements, in patients treated for anemia associated with chronic renal failure.
    E.2.2Secondary objectives of the trial
    To compare the safety and tolerability of epoetin (PLIVA) with epoetin alfa (Janssen Cilag) in patients treated for anemia associated with chronic renal failure
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Have chronic renal failure requiring regular hemodialysis, and receiving at least 6 months r HuEPO treatment (75 300 international units [IU]/kg per week either iv or subcutaneous) of which at least 3 months should be r-HUEPO maintenance therapy, prior to the Screening Visit.
    2. The hemodialysis is of adequate quality, defined as fractional urea clearance (Kt/Vurea) ³ 1.2 (within the 4 weeks prior to the Screening Visit).
    3. Have controlled Hb level of 10 to 13 g/dL during the last 8 weeks prior to the Screening Visit (mean value of 3 measurements 10-13 g/dL, difference between highest and lowest value no more than 2 g/dL, measurements at least 1 week apart). Be on stable dose of epoetin, i.e., no dose change during the last 8 weeks of r-HUEPO treatment.
    4. Are clinically stable (based on the investigator’s judgment) within the 3 months prior to the Screening Visit.
    5. Have adequate iron stores (serum ferritin > 100 mg/L and TfS > 20%) at the Screening Visit. Patients who meet all other criteria will be given iron therapy and be re-screened after 2 weeks. All study assements of the screening visit (exept for written informed consent; demographics/medical history, serology; vitamin B12 and folic acid) must be repeated as soon as the time between the screening and first dosing exeeds 2 weeks (+ 3 day window). The type of iron therapy chosen will be at the discretion of the investigator, and according to local requirements.
    6. Are aged 18 to 75 years.
    7. Females of childbearing potential must have a negative serum pregnancy test at screening and be practicing an acceptable method of birth control during the study and for up to 1 month after the last dose of the study drug.
    Acceptable methods (which have a failure rate of < 1% a year) include: hormonal implants and injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomized partners. Female patients must not be nursing an infant during the study. Sexually active male patients must take appropriate actions to avoid pregnancy with any partner.
    E.4Principal exclusion criteria
    1. Have had treatment with long-acting epoetin analogues, such as Aranesp, or are receiving maintenance does of r-HuEPO >300 IU/kg per week.
    2. Have had treatment for epilepsy with tonic clonic seizures within 6 months prior to the Screening Visit.
    3. Have congestive heart failure (New York Heart Association [NYHA] class III or IV).
    4. Have had a cerebrovascular accident, myocardial infarction, coronary angioplasty or bypass surgery within 6 months prior to the Screening Visit.
    5. Have uncontrolled hypertension, defined as 2 diastolic blood pressure measurements > 110 mmHg, and/or 2 systolic measurements > 180 mmHg, taken after dialysis within the 4 weeks prior to the Screening Visit. If one blood pressure measurement is increased above limits, another measurement will be taken after a 30 minute interval for confirmation.
    6. Have had major surgery within 3 months prior to the Screening Visit (excluding vascular access surgery).
    7. Have active inflammatory or malignant disease.
    8. Have been previously diagnosed with human immunodeficiency virus (HIV) or chronic hepatitis B or C virus infection. Patients who are hepatitis B surface antigen (HbsAg) or hepatitis C virus antibody (anti HCV) positive can be included if they have normal transaminases and are not on anti viral treatment.
    9. Have had a RBC transfusion(s) within 3 months prior to the Screening Visit or during the screening Period, or have chronic bleeding or clinically significant blood loss.
    10. Have any anemia with a cause other then chronic renal failure (e.g., hemolytic anemia including sickle cell disease, megaloblastic anemia, aplastic anemia, myelodysplasia, pure red cell aplasia).
    11. Are currently enrolled in any other investigational device or drug study, or have participated in another clinical study within 30 days prior to the Screening Visit.
    12. Are pregnant women or mothers who are breast feeding.
    13. Have a known hypersensitivity (drug intolerance or allergy) to r HuEPO, epoetin alfa (Janssen Cilag), or excipients of epoetin (PLIVA).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints for this study are:
    ·The difference in change from baseline (mean of last 2 readings of the open-label treatment period) to the mean of Weeks 26 and 28 (last 2 readings of the double-blind treatment period) in Hb concentration for each treatment
    ·The percentage change in mean weekly dose of study drugs at baseline (end of the open-label treatment period) to mean weekly dose during the last 4 weeks of the double-blind treatment period (Weeks 24-28) for each treatment

    Hb response is measured by assessing the combined mean at Weeks 10 and 12 to take into account possible Hb fluctuations.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    EPREX (Epoietin alfa)
    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
    see section 9.2.3 of the protocol:
    After completing the open-label treatment period at visit 10 an assessment will be made if the patient is optimally titrated according to this protocol. Optimally titrated patients will enter the double-blind treatment period. Patients that are not optimally titrated will discontinue their study medication.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    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 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 2005-08-30. 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.3.3.6.1Details of subjects incapable of giving consent
    section 6.1 of protocol:
    Females of childbearing potential must have a negative serum pregnancy test at screening and be practicing an acceptable method of birth control during the study and for up to 1 month after the last dose of the study drug.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 101
    F.4.2.2In the whole clinical trial 256
    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)
    Patients will undergo a follow-up visit at week 32 or 4 weeks after the last study drug administration.
    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 Decision2005-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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