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    Summary
    EudraCT Number:2004-000676-13
    Sponsor's Protocol Code Number:PRO-RENAL-REG-055
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-08-23
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2004-000676-13
    A.3Full title of the trial
    An Evaluation of the Efficacy of Epo-Omega in The Treatment of Anaemia in Chronic Kidney Disease (CKD) Patients When Administered by Once Weekly Subcutaneous Injection: A Dose Dependency Evaluation.
    A.3.2Name or abbreviated title of the trial where available
    Epomax (1 x / week s.c.) A dose dependency evaluation
    A.4.1Sponsor's protocol code numberPRO-RENAL-REG-055
    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 5000 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 IMPSubcutaneous 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 number5000
    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 developed 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 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 IMPSubcutaneous 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 developed 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 pre-dialysis Chronic Kidney Disease (CKD) Patients
    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
    The objective of this study is to evaluate the dose dependency of the anti-anaemic effects of Epoetin-Omega administered by once weekly subcutaneous (s.c.) injection in anaemic pre-dialysis CKD patients.
    E.2.2Secondary objectives of the trial
    The trial will particularly evaluate whether the effect of Epoetin Omega on blood pressure shows any dose-dependent trends.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Patients who have provided written informed consent.
    2. Patients with stable Hb <11.0g/dL (stable = at least two Hb measurements <11.0 g/dL, a minimum of 7 days apart, in a 42 day period prior to formal screening for the study AND then 3 Hb values taken at screening, in between the Screening Visit and Visit 0 (Day 1) and at Visit 0 (Day 1).
    3. A glomerular filtration rate (GFR) of 15-59 ml/min/1.73m2 (stage 3-4, mild to moderate renal impairment) as determined using the Cockcroft-Gault formula.
    4. Patients of 18 years of age and above.
    5. Patients with an adequate iron status defined as serum ferritin ≡100µg/L and transferrin saturation ≡20% at the Screening Visit.
    E.4Principal exclusion criteria
    1. Patients with uncontrolled hypertension (diastolic BP>100mm Hg determined on two separate occasions).
    2. Patients with Vit B12 deficiency (<200 ng/L) or folic acid deficiency (<3.0µg/L).
    3. Patients with a diagnosis of cancer (except skin cancer) currently under active treatment.
    4. Patients with haemolytic anaemia or anaemia due to other diseases.
    5. Patients with clinically persistent blood loss (e.g. gastrointestinal).
    6. Patients with known epilepsy.
    7. Patients with severe hyperparathyroidism with bone involvement and/or indication for parathyroidectomy.
    8. Pregnant or lactating patients.
    N.B. Female patients of childbearing potential must have a negative serum pregnancy test at the time of screening and will be required to use a medically acceptable means of contraception during their participation in this study.
    9. Patients who have received Interferon or Ribavirin within 30 days prior to the Screening Visit.
    10. Patients who have received Epoetin (Alpha, Beta) or Darbepoetin alfa treatment, androgens or transfusions within the last 90 days prior to the Screening Visit.
    11. Patients with acute infection(s).
    12. Patients with inflammatory status (CRP >30mg/L).
    13. Patients with HIV.
    14. Patients with biochemical evidence of significant liver disease (with transaminases >2X upper limit).
    15. Patients who have received cytotoxic agents, immunosuppressives or radiation therapy within 30 days prior to the Screening Visit.
    16. Patients participating in another interventional study.
    17. Patients who have received investigational drug within 30 days prior to the Screening Visit.
    18. Patients with known hypersensitivity to Epoetin, or mammalian cell line products or human serum albumin.
    19. Patients with a history of pure red cell aplasia (any cause).
    20. Patients with a history of anti-EPO antibodies.
    21. Patients with a serum albumin < 30 g/L.
    22. Patients with a life expectancy < 6 months.
    Patients who have had a renal transplant are allowed to participate in the study, as are those who are on the transplant waiting list. Those who are scheduled to have a living related donor operation within the next 3 months must be excluded.
    E.5 End points
    E.5.1Primary end point(s)
    1. Response rate. The Response Rate is the proportion of ‶responders※, where response to the assigned dose is defined as Packed Red Cell (PRC) transfusion-independent attainment of Hb levels during the trial that meet one of the following criteria: a) two consecutive weekly Hb values >1.0 g/dL higher than the baseline Hb (HbB); b) Hb level is >13.0 g/dL at least once, c) reduction in Epoetin dose due to a too rapid increase in Hb (i.e. > 2.5 g/dL/2 weeks).
    The baseline Hb level is defined as the average value of three Hb concentrations determined at the Screening Visit, in between the Screening Visit and Visit 0, and at Visit 0.
    2. The weekly change in Hb until the end of the study. This parameter is defined as the weekly consecutive differences in Hb for each patient (Hbi - Hbi-1, where i is the visit number and may range from 1 to 12). For Visit 1, the value Hbi-1 is the baseline Hb value. The duration of the observed period is from enrolment until one of the following events (whichever occurs first).
    a) The Hb level > 13 g/dL.
    b) Patient requires an Epoetin dose increase.
    c) Patient requires an Epoetin dose decrease.
    d) Patient receives a PRC transfusion.
    e) Patient drops out of the study and Hb values are no longer available.
    f) The planned end of the study (completed 12 weeks).
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    other dose of same medicinal product used as calibrator arm
    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 12 (Week 12) 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 2004-08-23. 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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 105
    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 Decision2004-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
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