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    Summary
    EudraCT Number:2021-003088-87
    Sponsor's Protocol Code Number:WWU20_0016
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-16
    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 number2021-003088-87
    A.3Full title of the trial
    Biomarker-guided implementation of angiotensin-II (AT-II) to reduce the occurrence of kidney damage after cardiac surgery
    Biomarker-gesteuerter Einsatz von Angiotensin II zur Verringerung des Auftretens einer akuten Nierenschädigung (AKI) nach Herzoperationen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Reduction of occurence of Acute Kidney Injury through administration of angiotensin-II
    Reduktion des Auftretens einer akuten Nierenschädigung durch die Gabe von Glutamin
    A.3.2Name or abbreviated title of the trial where available
    AIDED
    A.4.1Sponsor's protocol code numberWWU20_0016
    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 SponsorWestfälische Wilhelms-Universität Münster
    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 supportDeutsche Forschungsgemeinschaft
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Muenster
    B.5.2Functional name of contact pointDept. of Anesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressAlbert-Schweitzer-Campus 1, A1
    B.5.3.2Town/ cityMuenster
    B.5.3.3Post code48149
    B.5.3.4CountryGermany
    B.5.4Telephone number+4902518347252
    B.5.5Fax number+4902518340501
    B.5.6E-mailaki@anit.uni-muenster.de
    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 GIAPREZA 2.5 mg/ml concentrate for solution for infusion angiotensin II
    D.2.1.1.2Name of the Marketing Authorisation holderPaion
    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 Concentrate for 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 INNANGIOTENSIN II
    D.3.9.1CAS number 4474-91-3
    D.3.9.3Other descriptive nameAngiotensin II acetate
    D.3.9.4EV Substance CodeSUB05510MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cardiac surgical patients at high risk for AKI
    Herzchirurgische Patienten mit hohem Risiko für die Entwicklung einer AKI
    E.1.1.1Medical condition in easily understood language
    Cardiac surgical patients at high risk for acute kidney injury
    Herzchirurgische Patienten mit einem hohen Risiko für die Entwicklung einer akuten Nierenschädigung
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10069339
    E.1.2Term Acute kidney injury
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080266
    E.1.2Term Stage 1 acute kidney injury
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080269
    E.1.2Term Stage 2 acute kidney injury
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080271
    E.1.2Term Stage 3 acute kidney injury
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10017501
    E.1.2Term Functional disturbances following cardiac surgery
    E.1.2System Organ Class 100000004863
    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 this trial is to investigate the efficacy of Angiotensin-II vs. standard of care on the biomarkers [TIMP-2]*[IGFBP7] in high-risk patients undergoing cardiac surgery.
    Das primäre Ziel ist es, bei Hochrisikopatienten die Wirksamkeit von Angtiotensin-II auf den Biomarker [TIMP-2]*[IGFBP7] zu untersuchen.
    E.2.2Secondary objectives of the trial
    • occurrence of AKI within 72h after cardiac surgery
    • occurrence of moderate and severe AKI within 72h after cardiac surgery
    • amount of volume application
    • transient (<72h) and persistent (<72h) AKI
    • fluid status
    • dose and duration of vasopressor use
    • creatinine clearance on day one after cardiac surgery
    • free-days through day 28 of vasoactive medications and mechanical ventilation
    • renal recovery at day 90
    • 30-day, 60-day and 90-day mortality
    • length of ICU stay
    • length of hospital stay
    • use and duration of renal replacement therapy within hospital stay
    • use of RRT at days 30, 60, 90
    • MAKE90
    • Effect of ACEi/ARBs use on the AT II effect
    • Correlation between the severity of hyperreninemia and the AT II effect
    • Auftreten einer akuten Nierenschädigung innerhalb von72h nach herzchirurgischem Eingriff
    • Auftreten von moderatem und schwerem AKI innerhalb von 72 h nach herzchirurgischem Eingriff
    • Flüssigkeitszufuhr
    • transientes (<72h) and persistentes (<72h) AKI
    • Flüssigkeitsbilanz
    • Dosis und Dauer des Vasopressoreinsatzes
    • Kreatinine-Clearance einen Tag nach dem herzchirurgischen Eingriff
    • Katecholaminfreie sowie beatmungsfreie Tage bis Tag 28
    • Renale Erholung an Tag 90
    • 30-Tage, 60-Tage und 90-Tage Mortalität
    • Dauer des ICU-Aufenthalts
    • Krankenhausaufenthaltsdauer
    • Notwendigkeit und Dauer eines Nierenersatzverfahrens (RRT) während des Krankenhausaufenthaltes
    • Notwendigkeit eines RRT an den Tagen 30, 60 und 90
    • MAKE90
    • Wirkung des Einsatzes von ACEi/ARBs auf den Effekt von AT-II
    • Korrelation zwischen dem Schweregrad der Hyperreninämie und dem AT-II-Effekt
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult patients scheduled for cardiac surgery with cardiopulmonary bypass (CPB),
    2. 18 years of age or older,
    3. cardiac index > 2.1 l/min per square meter,
    4. Written informed consent.
    Registered patients will be randomized only if
    1. Δ-renin (difference between post- and pre-operation) ≥ 3.7 µU/ml 4h after CPB.
    2. postoperative hypotension requiring vasopressors
    1. Erwachsene Patienten mit einem geplanten kardiochirurgischen Eingriff mit Notwendigkeit es Einsatzes der Herz-Lungen-Maschine (HLM),
    2. 18 Jahre oder älter,
    3. kardialer Index > 2.1 l/min pro m2,
    4. Written informed consent
    Registrierte Patienten werden nur randomisiert wenn die folgende Parameter erfüllt sind:
    1. Δ-renin (Difference zwischen post- and prä-Operation) ≥ 3.7 µU/ml 4h nach HLM.
    2. postoperative Hypotension die den Einsatz von Vasopressoren erfordert
    E.4Principal exclusion criteria
    1. Preexisting AKI (stage 1 and higher)
    2. Patients with cardiac assist devices (ECMO, LVAD, RVAD, IABP)
    3. Pregnant women, breastfeeding women and women of childbearing potential
    4. Known (Glomerulo-) Nephritis, interstitial nephritis or vasculitis
    5. Chronic kidney disease with eGFR < 20 ml/min/1.73m2
    6. Dialysis dependent CKD
    7. Prior kidney transplant within the last 12 months
    8. Emergency surgery in the context of an acute coronary syndrome
    9. Hypersensitivity to the active substance, or to any of the excipients of the study medication
    10. Bronchospasm
    11. Liver failure
    12. Mesenteric ischemia
    13. Participation in another intervention trial in the past 3 months
    14. Persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
    15. Persons held in an institution by legal or official order
    1. Vorbestehende AKI (Stadium 1 und höher)
    2. Patients mit Kreislausunterstützungssystemen (ECMO, LVAD, RVAD, IABP)
    3. Schwangere oder stillende Frauen und Frauen im gebärfähigen Alter
    4. Vorbestehende (Glomerulo-) Nephritis, interstitielle Nephritis oder Vaskulitis
    5. Chronische Nierenerkrankung (CKD) mit eGFR < 20 ml/min/1.73m2
    6. Dialysepflichtige CKD
    7. Z.n. Nierentransplantation innerhalb der letzten 12 Monate
    8. Notfalleingriff im Kontext eines akuten Koronarsyndroms
    9. Vorbekannte Überempfindlichkeit gegenüber der aktiven Substanz oder eines Inhaltsstoffes der Studienmedikation
    10. Bronchospasmus
    11. Leberversagen
    12. Mesenteriale Ischämie
    13. Teilnahme an einer anderen Interventionsstudie innerhalb der letzten 3 Monate
    14. Abhängigkeit zum Prüfer oder Zentrum
    15. Patienten, die auf behördliche Anordnung in einer geschlossenen Einrichtung untergebracht sind.
    E.5 End points
    E.5.1Primary end point(s)
    • kidney damage after cardiac surgery identified by the difference between [TIMP-2]*[IGFBP7] levels 12h after randomization and [TIMP-2]*[IGFBP7] levels at randomization
    • Akute Nierenschädigung nach herzchirurgischen Eingriffen, identifiziert durch den Unterschied zwischen dem [TIMP-2]*[IGFBP7] Level 12h nach der Randomisation und [TIMP-2]*[IGFBP7] Level bei Randomisation
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 h after start of intervention
    12 h nach Start der Intervention
    E.5.2Secondary end point(s)
    • occurrence of AKI within 72h after cardiac surgery (according to the KDIGO criteria)
    • occurrence of moderate and severe AKI within 72h after cardiac surgery (according to the KDIGO stage 2 and 3)
    • amount of volume application
    • transient (<72h) and persistent (<72h) AKI
    • fluid status
    • dose and duration of vasopressor use
    • creatinine clearance on day one after cardiac surgery
    • free-days through day 28 of vasoactive medications and mechanical ventilation
    • renal recovery at day 90 (renal recovery is defined as serum creatinine levels < 0.5 mg/dl higher than baseline serum creatinine (creatinine level before surgery)
    • 30-day, 60-day and 90-day mortality
    • length of ICU stay
    • length of hospital stay
    • use and duration of renal replacement therapy within hospital stay
    • use of RRT at days 30, 60, 90
    • MAKE90 (major adverse kidney events consisting of mortality, dialysis dependency, persistent renal dysfunction (defined as serum creatinine ≥ 2x compared to baseline value) at day 90
    • Effect of ACEi/ARBs use on the AT II effect
    • Correlation between the severity of hyperreninemia and the AT II effect
    • Auftreten einer akuten Nierenschädigung innerhalb von72h nach herzchirurgischem Eingriff definiert nach KDIGO
    • Auftreten von moderatem und schwerem AKI innerhalb von 72 h nach herzchirurgischem Eingriff (gemäß KDIGO Stadium 2 und 3)
    • Flüssigkeitszufuhr
    • transientes (<72h) and persistentes (<72h) AKI
    • Flüssigkeitsbilanz
    • Dosis und Dauer des Vasopressoreinsatzes
    • Kreatinine-Clearance einen Tag nach dem herzchirurgischen Eingriff
    • Katecholaminfreie sowie beatmungsfreie Tage bis Tag 28
    • Renale Erholung an Tag 90 (definiert als Serumkreatininlevel < 0,5 mg/dl höher als Baseline-Kreatinin vor chirurgischem Eingriff (Kreatininlevel vor der Operation)
    • 30-Tage, 60-Tage und 90-Tage Mortalität
    • Dauer des ICU-Aufenthalts
    • Krankenhausaufenthaltsdauer
    • Notwendigkeit und Dauer eines Nierenersatzverfahrens (RRT) während des Krankenhausaufenthaltes
    • Notwendigkeit eines RRT an den Tagen 30, 60 und 90
    • MAKE90 (major adverse kidney events bestehend aus den Kriterien Mortalität, Dialysepflichtigkeit, persistierende renale Dysfunktion (definiert als Serumkreatinin ≥ 2x im Vergleich zum Baselinewert) an Tag 90
    • Wirkung des Einsatzes von ACEi/ARBs auf den Effekt von AT-II
    • Korrelation zwischen dem Schweregrad der Hyperreninämie und dem AT-II-Effekt
    E.5.2.1Timepoint(s) of evaluation of this end point
    72 hours after cardiac surgery
    30 days after cardiac surgery
    60 days after cardiac surgery
    90 days after cardiac surgery
    72 Stunden nach der Herzoperation
    30 Tage nach der Herzoperation
    60 Tage nach der Herzoperation
    90 Tage nach der Herzoperation
    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 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) 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) No
    E.8.2.2Placebo Yes
    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 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 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
    LVLS
    Letzter Besuch des letzten Patienten
    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 months6
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days15
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 39
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state64
    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)
    Specific post-treatment is not required. The study interventions do not have consequences for the subsequent medical care. According to the
    current state of knowledge, there is no indication for the occurrence of
    long-term consequences after a therapy with the study medication.
    Nevertheless a follow-up at day 30 and 90 will be conducted to clarify
    the objectives of the clinical trial.
    The further treatment is carried out according to the local standard of
    the study site.
    Eine spezifische Nachbehandlung ist nicht erforderlich. Die Studieninterventionen haben keine Konsequenzen für die spätere medizinische Versorgung. Nach dem derzeitigen Kenntnisstand gibt es
    keine Hinweise auf das Auftreten von Langzeitfolgen nach einer Therapie mit der Studienmedikation. Dennoch wird an Tag 30 und 90 ein Follow-up durchgeführt, um die Ziele der klinischen Studie zu klären.
    Die weitere Behandlung erfolgt nach dem lokalen Standard des
    Untersuchungsortes.
    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 Decision2021-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-16
    P. End of Trial
    P.End of Trial StatusOngoing
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