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    Summary
    EudraCT Number:2016-002162-30
    Sponsor's Protocol Code Number:HC-G-H-1504
    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:2020-06-09
    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 number2016-002162-30
    A.3Full title of the trial
    Prospective, randomized, controlled, double-blind, multicentre, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Controlled, international study conducted in several centres on the safety and therapeutic effect of a Hydroxylethyl-starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery
    A.3.2Name or abbreviated title of the trial where available
    PHOENICS
    A.4.1Sponsor's protocol code numberHC-G-H-1504
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFresenius Kabi Deutschland GmbH
    B.1.3.4CountryGermany
    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 supportB. Braun Melsungen AG
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportFresenius Kabi Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFresenius Kabi Deutschland GmbH
    B.5.2Functional name of contact pointUlf Niess
    B.5.3 Address:
    B.5.3.1Street AddressElse-Kröner-Straße 1
    B.5.3.2Town/ cityBad Homburg v.d.H.
    B.5.3.3Post code61352
    B.5.3.4CountryGermany
    B.5.4Telephone number004961726864115
    B.5.5Fax number004961726867542
    B.5.6E-mailulf.niess@fresenius-kabi.com
    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 Yes
    D.2.1.1.1Trade name Volulyte 6% Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Deutschland GmbH
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNPoly(O-2-hydroxyethyl)starch
    D.3.9.1CAS number 9005-27-0
    D.3.9.3Other descriptive nameHydroxyethyl starch 130/0.4
    D.3.9.4EV Substance CodeSUB90155
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60.00
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.02
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPotassium chloride
    D.3.9.1CAS number 7447-40-7
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagensium chloride hexahydrate
    D.3.9.1CAS number 7791-18-6
    D.3.9.3Other descriptive nameMAGNESIUM CHLORIDE HEXAHYDRATE
    D.3.9.4EV Substance CodeSUB12526MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium acetate trihydrate
    D.3.9.1CAS number 6131-90-4
    D.3.9.3Other descriptive nameSODIUM ACETATE TRIHYDRATE
    D.3.9.4EV Substance CodeSUB15266MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.63
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.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 Yes
    D.2.1.1.1Trade name Elonorm Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Austria GmbH, Hafnerstraße 36, A-8055 Graz
    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 nameElonorm Infusionslösung
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNSodium chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.02
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPotassium chloride
    D.3.9.1CAS number 7447-40-7
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagnesium chloride hexahydrate
    D.3.9.1CAS number 7791-18-6
    D.3.9.3Other descriptive nameMAGNESIUM CHLORIDE HEXAHYDRATE
    D.3.9.4EV Substance CodeSUB12526MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium acetate trihydrate
    D.3.9.1CAS number 61341-90-4
    D.3.9.3Other descriptive nameSODIUM ACETATE TRIHYDRATE
    D.3.9.4EV Substance CodeSUB15266MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.63
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Hypovolaemia due to acute blood loss in elective abdominal surgery
    E.1.1.1Medical condition in easily understood language
    Decreased blood volume due to acute blood loss during scheduled surgery of the abdomen
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021137
    E.1.2Term Hypovolaemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    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 the study is to investigate non-inferiority regarding the safety of a 6 % HES solution for infusion compared to an electrolyte solution for infusion in patients with acute blood loss during elective abdominal surgery.
    Difference in mean estimated glomerular filtration rate (eGFR) (calculated from highest cystatin-C levels measured during post-operative days 1-3 (POD 1-3)) between the two treatment groups. This difference will be calculated for the change from the pre-operative baseline value.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to further assess safety and efficacy, e.g. on renal function, blood coagulation, inflammation, haemodynamics, total administered IP volume over the study time, fluid balance, concomitant medication, need of blood products, (serious) adverse events, in-hospital mortality, and several outcome parameters. Additionally (serious) adverse events, major post-operative complications (including renal) and mortality will be evaluated until day 90 and renal function will be followed-up by monitoring eGFR at day 28 and day 90 after surgery. One year after surgery mortality and renal outcome will be re-assessed by using a telephone call. For details refer to section 10.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The following inclusion criteria apply:
    • Male or female adult patients > 40 and ≤ 85 years of age. Women of child bearing potential must test negative on standard pregnancy test (urine or serum)
    • Patients undergoing elective abdominal surgery with an expected blood loss of ≥ 500 ml
    • ASA Physical Status II – III
    • Signed written informed consent form
    E.4Principal exclusion criteria
    Patients will not be considered for participation in the study if any of the following criteria listed below apply:
    • Hypersensitivity to the active substances or to any of the other excipients of the IPs
    • Body weight ≥ 140 kg
    • Sepsis
    • Burns
    • Renal impairment (defined as AKIN stage ≥ 1 or chronic), or acute and/or chronic renal replacement therapy
    • Intracranial or cerebral haemorrhage
    • Critically ill patients (typically admitted to the intensive care unit)
    • Hyperhydration
    • Pulmonary oedema
    • Dehydration
    • Hyperkalaemia
    • Severe hypernatraemia
    • Severe Hyperchloraemia
    • Severely impaired hepatic function
    • Congestive heart failure
    • Severe coagulopathy
    • Organ transplant patients
    • Metabolic alkalosis
    • Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
    E.5 End points
    E.5.1Primary end point(s)
    Difference in mean estimated glomerular filtration rate (eGFR) between the two treatment groups, calculated form the highest Cystatin-C level measured during post-operative days (POD) 1-3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cystatin-C levels will be determined on POD 1-3. eGFR will be calculated from the highest Cystatin-C level during this period.
    E.5.2Secondary end point(s)
    Major complications including renal impairment have been recognized very frequently among high-risk surgery patients (Pearse et al., 2014, Hamilton et al., 2011) and are considered as secondary endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cystatin-C: T0, T2-T8
    SCr: T0, T2, T3, T4, T7, T8
    Cystatin-C-b eGFR: T0, T2, T3, T4, T7, T8
    Cystatin-C-b mean eGFR: T3-T6
    SCr-b eGFR: T0, T2, T3, T4, T7, T8
    AKIN stage: T0, T2, T3, T4, T7, T8
    RIFLE cat: T0, T2, T3, T4, T7, T8
    Urine output: T0, T1, T3-T4
    Coagulation: T0, T2, T3
    C-RP: T0, T2, T3
    (S)AEs/(S)ARs: T0-T8
    Blood loss - RBC:T4 & intra-op: T2
    LOS-H, LOS-ICU, Fit for discharge - H & ICU: daily
    MV: T0-T5
    Mortality + maj p-o compl. (incl. renal): Cum. from T2 until T8
    RRT dur
    new RRT: T7, T8, T9
    IP intake, fluid in-/output, fluid bal: T0-T4
    T: T0, T2-T4
    MAP, HR, SAP, DAP, CVP: T0, T1 (at least q 30 min), T2; MAP, HR also T2-T4
    vol guide: during IP admin
    ABGA: T0 + T2 (all); T3 + T4 (only Hb, Hct, lactate)
    ScvO2: T0, T2, T3
    S Elyte: T0, T2, T3
    Maj compl: T3-T8
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Croatia
    Czechia
    France
    Germany
    Italy
    Netherlands
    Romania
    Serbia
    South Africa
    E.8.7Trial has a data monitoring committee Yes
    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
    Day 90 after surgery ± 14 days of the last patient
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    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.1.2.1Number of subjects for this age range: 1500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 780
    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 2020-06-09. 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 2280
    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)
    Not different from the expected normal treatment of the condition.
    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 Decision2020-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-06
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