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    Summary
    EudraCT Number:2012-003696-18
    Sponsor's Protocol Code Number:uni-koeln-1547
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-01
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-003696-18
    A.3Full title of the trial
    Effect of a preinterventional calorie restriction on renal function after contrast agent exposition in patients at risk.
    Einfluss einer präinterventionellen kalorienreduzierten Diät auf die Nierenfunktion nach Kontrastmittelexposition bei Risikopatienten.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    By conducting this trial, it will be investigated if a short-term calorie restriction can protect the kidney from the negative influence of contrast agent.
    Es soll untersucht werden, ob eine kurzfristige Kalorienreduktion vor Kontrastmittelgabe die Entwicklung eines durch Kontrastmittel verursachten Nierenversagens günstig beeinflusst.
    A.3.2Name or abbreviated title of the trial where available
    CR_KMN
    A.4.1Sponsor's protocol code numberuni-koeln-1547
    A.5.4Other Identifiers
    Name:DRKSNumber:00004361
    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 SponsorUniversity of Cologne
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity of Cologne
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Cologne
    B.5.2Functional name of contact pointClinic II Internal Medicine
    B.5.3 Address:
    B.5.3.1Street AddressKerpener Str. 62
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50937
    B.5.3.4CountryGermany
    B.5.4Telephone number004922147897222
    B.5.5Fax number004922147832999
    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 Accupaque
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare Buchler GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIOHEXOL
    D.3.9.1CAS number 66108-95-0
    D.3.9.4EV Substance CodeSUB08228MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    contrast-induced nephropathy, acute renal failure
    Kontrastmittelnephropathie, akutes Nierenversagen
    E.1.1.1Medical condition in easily understood language
    renal failure after contrast agent administration
    Nierenversagen nach Kontrastmittelgabe
    E.1.1.2Therapeutic area Not possible to specify
    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
    The intention of this trial is to investigate, if a short-term calorie restriction before contrast agent administration can prevent contrast induced nephropathy.
    Es soll im Sinne eines „proof of concept“ untersucht werden, ob eine kurzfristige Kalorienreduktion vor Kontrastmittelexposition die Entwicklung einer Kontrastmittelnephropathie günstig beeinflusst.
    E.2.2Secondary objectives of the trial
    Analysis of the increase of serum creatinine 24h after the onset of coronary intervention (contrast agent exposition); Neutrophil gelatinase-associated lipocalin (NGAL in µg/l) in urine 24h after the onset of coronary intervention (contrast agent exposition); Cystatin C in plasma (mg/l) 24h after the onset of coronary intervention (contrast agent exposition)
    Anstieg des Serumkreatinins in mg/dl 24 h nach Beginn der Koronarintervention;
    Neutrophilen-Gelatinase assoziiertes Lipocalin (NGAL in µg/l) im Urin 24h nach Beginn der Koronarintervention (Kontrastmittelexposition);
    Cystatin C im Plasma (mg/l) 24 h nach nach Beginn der Koronarintervention (Kontrastmittelexposition)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. men and women 18 years of age or older
    2. caucasian origin
    3. scheduled coronary angiography
    4. indication for coronary angiography is determined by the referring physician
    5. Patient and/or legal guardian must be willing and able to give written
    informed consent
    6. at least one of the following risk factors:
    •serumkreatinine > 1,1 mg/dl in male patients or serumkreatinin > 0,9 mg/dl in
    female patients
    •Diabetes mellitus
    •peripher arteriovascular disease
    •heartfailure with NYHA 3-4 or ejection fraction ≤ 50%
    •age over 70 years
    1. Männer und Frauen über 18 Jahre;
    2. Kaukasische Abstammung;
    3. elektive Koronarangiographie;
    4. die Indikationsstellung zur Koronarangiographie erfolgt durch die betreuenden
    zuweisenden Ärzte oder durch die Kliniken für Innere Medizin der Uniklinik
    Köln;
    5. Schriftliches Einverständnis bei vorliegender Geschäftsfähigkeit;
    6. Mindestens einer der folgenden Risikofaktoren (nach Aktenlage):
    •Serumkreatinin > 1,1 mg/dl bei Männern oder Serumkreatinin > 0,9 mg/dl bei
    Frauen
    •Diabetes mellitus
    •pAVK
    •Herzinsuffizienz mit NYHA 3-4 oder EF ≤ 50%
    •Alter über 70 Jahre
    E.4Principal exclusion criteria
    1. End-stage renal disease (patient on dialysis);
    2. Indwelling kidney transplant;
    3. Malnutrition (BMI < 18,5 kg/m2);
    4. Body weight < 46 kg in male, < 51 kg in female;
    5. BMI > 35 kg/m2 or body weight > 120 kg;
    6. diet within the previous 4 weeks;
    7. Inappetence ;
    8. Weight loss > 1 kg within the previous 2 weeks, if not explained by use of
    diuretics;
    09. Consuming underlying disease;
    10. Uncontrolled local or systemic infection;
    11. Contraindication for enteral nutrition;
    12. Known allergy against or incompatibility with ingredients of the employed
    formula-diet;
    13. Pregnancy or breast feeding;
    14. Participation in other interventional clinical trials;
    15. Missing safe method of contraception or missing occurence of menopause
    (in female);
    16. Professional or private relationship between subject and the investigators
    or dependence on the investigators;
    17. Placement in an institution based on official orders.
    1. terminale Niereninsuffizienz (Dialysepflichtigkeit);
    2. Zustand nach Nierentransplantation;
    3. Unterernährung (BMI < 18,5 kg/m2);
    4. Körpergewicht:< 46 kg bei Männern, < 51 kg bei Frauen;
    5. BMI > 35 kg/m2 oder Körpergewicht > 120 kg;
    6. kalorienreduzierte Diät innerhalb der vorangegangenen 4 Wochen;
    7. Inappetenz;
    8. Gewichtsverlust > 1 kg in den letzten 2 Wochen, sofern nicht durch
    Diuretika erklärt;
    9. konsumierende Grunderkrankung;
    10. unkontrollierter lokaler oder systemischer Infekt;
    11. Kontraindikation für eine enterale Ernährung;
    12. Bekannte Allergie oder Unverträglichkeit gegen Inhaltsstoffe der
    eingesetzten Formula-Diät;
    13. Schwangerschaft oder Stillzeit;
    14. Teilnahme an anderen interventionellen Prüfungen;
    15. Fehlende sichere Empfängnisverhütungsmaßnahmen oder fehlender Eintritt
    der Menopause (bei Frauen);
    16. Personen, die in einem Abhängigkeits- / Arbeitsverhältnis zu den Prüfern
    stehen;
    17. Unterbringung in einer Anstalt aufgrund gerichtlicher oder behördlicher
    Anordnung
    E.5 End points
    E.5.1Primary end point(s)
    Analysis of the increase of serum creatinine 48h after the onset of coronary intervention (contrast agent exposition).
    Anstieg des Serumkreatinins in mg/dl 48 h nach Beginn der Koronarintervention (Kontrastmittelexposition).
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours after intervention
    48 Stunden nach Intervention
    E.5.2Secondary end point(s)
    Analysis of the increase of serum creatinine 24h after the onset of coronary intervention (contrast agent exposition); Neutrophil gelatinase-associated lipocalin (NGAL in µg/l) in urine 24h after the onset of coronary intervention (contrast agent exposition); Cystatin C in plasma (mg/l) 24h after the onset of coronary intervention (contrast agent exposition)
    Anstieg des Serumkreatinins in mg/dl 24 h nach Beginn der Koronarintervention;
    Neutrophilen-Gelatinase assoziiertes Lipocalin (NGAL in µg/l) im Urin 24h nach Beginn der Koronarintervention (Kontrastmittelexposition);
    Cystatin C im Plasma (mg/l) 24 h nach nach Beginn der Koronarintervention (Kontrastmittelexposition)
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 hours after intervention
    24 Stunden nach Intervention
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 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
    Keine Kalorienreduktion.
    No calorie restriction.
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state80
    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 return to standard medical treatment for their condition.
    Patienten werden entsprechend der Standardversorgung weiterbehandelt.
    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 Decision2013-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-07
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