Clinical trial • Nephrology | Cardiology
Angiotensin II for Acute kidney injury | Cardiac surgery-associated acute kidney injury
Clinical trial of Angiotensin II for Acute kidney injury | Cardiac surgery-associated acute kidney injury.
Overview
- Trial Therapeutic Area
- Nephrology | Cardiology
- Trial Disease
- Acute kidney injury | Cardiac surgery-associated acute kidney injury
- Drug Modality
- Peptide/protein/enzyme | Small molecule
Key dates
- Initial CTIS Submission Date
- 03-12-2024
- First CTIS Authorization Date
- 06-02-2025
Trial design
Randomised, norepinephrine (norepinephrine; noradrenaline tartrate) — infusion bag containing norepinephrine 0.1 mg/ml (intravenous perfusion). reported maximums in dataset: max daily dose amount 4.3 (mg/kg), max total dose amount 13 (mg/kg).-controlled, adaptive trial across 15 sites in Germany.
- Randomised
- Yes
- Comparator
- Norepinephrine (NOREPINEPHRINE; noradrenaline tartrate) — infusion bag containing norepinephrine 0.1 mg/ml (intravenous perfusion). Reported maximums in dataset: max daily dose amount 4.3 (mg/kg), max total dose amount 13 (mg/kg).
- Adaptive
- True, the design includes an interim analysis with a planned sample of approximately 1022 patients and the possibility to increase enrollment up to 1222 patients based on interim results.
- Target Sample Size
- 1022
- Trial Duration For Participant
- 120
Stratification factors
- site
- type of surgical procedure (coronary artery bypass graft, valve surgery, combined CABG/valve surgery)
Eligibility
Recruits 1022 The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). Participants are adults (Adult ≥ 18 years) and must provide written informed consent. No minors are included and no assent procedures are described..
- Pregnancy Exclusion
- Pregnancy (a negative pregnancy test for women of childbearing age) or breastfeeding women
- Vulnerable Population
- The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). Participants are adults (Adult ≥ 18 years) and must provide written informed consent. No minors are included and no assent procedures are described.
Inclusion criteria
- {"criterion_text":"- Cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG) surgery, valve surgery, or combined CABG/valve surgery\n- Elevated risk of AKI as predicted by a score ≥ 1.5 on the following scale: a.\themoglobin < 130g/l \t\t= 2 b.\tcreatinine > 1.1 mg/dl \t= 2 c.\tage > 70 years \t\t=1.5 d.\tNYHA 4 \t\t\t=1.5 e.\tBMI > 30 \t\t\t=1.5\n- Adult ≥ 18 years\n- Written informed consent"}
Exclusion criteria
- {"criterion_text":"- Major aortic surgery (aortic arch replacement), transplant surgery, pulmonary thrombendarterectomy, ventricular assist device placement\n- Persons with any kind of dependency on the investigator or employed by the sponsor/investigator\n- Participation in another interventional trial within the last three months that investigates kidney function\n- Already receiving inotropic/vasopressor support before surgery\n- Dialysis dependent\n- Pre-existing AKI within the last 30 days\n- Pre-existing chronic kidney injury with an eGFR<20 ml/min/1.73m2\n- Pre-existing significant hypertension (persistent SBP > 180mmHg)\n- Significant pulmonary hypertension (ePSAP > 70mmHg, mPAP > 40mmHg) with right ventricular systolic dysfunction (graded more severe than mild)\n- Hypersensitivity to the active substance or to any of the excipients of angiotensin II and norepinephrine (e.g. sodium metabisulfite, sulfite, chlorobutanol hemihydrate and sodium chloride and water)\n- Pregnancy (a negative pregnancy test for women of childbearing age) or breastfeeding women"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Rate of AKI KDIGO stage 2 or 3 or death within 72 hours after cardiac surgery","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- MAKE90 (consisting of mortality, any dialysis within 90 days, persistent renal dysfunction (defined as > 25% eGFR reduction to baseline value at day 90)","definition_or_measurement_approach":"Composite endpoint consisting of mortality, any dialysis within 90 days, persistent renal dysfunction defined as >25% eGFR reduction to baseline value at day 90."}
- {"endpoint_text":"- Development or progression of chronic kidney disease based on albuminuria and on two serum creatinine measurements between day 90 and 120","definition_or_measurement_approach":"Assessment based on albuminuria and two serum creatinine measurements taken between day 90 and day 120."}
Recruitment
- Planned Sample Size
- 1022
- Recruitment Window Months
- 27
- Consent Approach
- Written informed consent is required from adult participants. A subject information sheet and informed consent form for adults is listed (document: L1_SIS and ICF adults). No assent for minors is described and no specific languages for consent documents are specified in the available data.
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 1022
Germany
- Earliest CTIS Part Ii Submission Date
- 15-01-2025
- Latest Decision Or Authorization Date
- 09-07-2025
- Processing Time Days
- 175
- Number Of Sites
- 15
- Number Of Participants
- 1022
Sites
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie
- Principal Investigator Name
- Patrick Meybohm
- Principal Investigator Email
- Meybohm_P@ukw.de
- Contact Person Name
- Patrick Meybohm
- Contact Person Email
- Meybohm_P@ukw.de
- Site Name
- Klinikgruppe Dr. Guth GmbH & Co. KG
- Department Name
- Intensive Care Medicine; Heart- and Diabetes Center
- Principal Investigator Name
- Matthias Heringlake
- Principal Investigator Email
- heringlake@drguth.de
- Contact Person Name
- Matthias Heringlake
- Contact Person Email
- heringlake@drguth.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Klinik und Poliklinik für Anästhesiologie Zentrum für Anästhesiologie und Intensivmedizin
- Principal Investigator Name
- Bernd Saugel
- Principal Investigator Email
- b.saugel@uke.de
- Contact Person Name
- Bernd Saugel
- Contact Person Email
- b.saugel@uke.de
- Site Name
- Herzzentrum Dresden GmbH Universitaetsklinik
- Department Name
- Herzzentrum Dresden, TU Dresden
- Principal Investigator Name
- Klaus Matschke
- Principal Investigator Email
- Klaus.Matschke@herzzentrum-dresden.com
- Contact Person Name
- Klaus Matschke
- Contact Person Email
- Klaus.Matschke@herzzentrum-dresden.com
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- University Hospital Bonn; Klinik für Anästhesiologie und Operative Intensivmedizin
- Principal Investigator Name
- Christian Bode
- Principal Investigator Email
- christian.bode@ukbonn.de
- Contact Person Name
- Christian Bode
- Contact Person Email
- christian.bode@ukbonn.de
- Site Name
- Friedrich-Schiller-Universitaet Jena
- Department Name
- Department of Anesthesiology and Intensive Care Medicine
- Principal Investigator Name
- Johannes Ehler
- Principal Investigator Email
- Johannes.Ehler@med.uni-jena.de
- Contact Person Name
- Johannes Ehler
- Contact Person Email
- Johannes.Ehler@med.uni-jena.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Department of Anesthesiology
- Principal Investigator Name
- Reiner Wäschle
- Principal Investigator Email
- Reiner.Waeschle@med.uni-goettingen.de
- Contact Person Name
- Reiner Wäschle
- Contact Person Email
- Reiner.Waeschle@med.uni-goettingen.de
- Site Name
- Deutsches Herzzentrum Muenchen Klinikum Der Technischen Universitaet Muenchen
- Department Name
- Klinik für Herz- und Gefäßchirurgie
- Principal Investigator Name
- Johannes Böhm
- Principal Investigator Email
- johannes.boehm@dhm.mhn.de
- Contact Person Name
- Johannes Böhm
- Contact Person Email
- johannes.boehm@dhm.mhn.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Department of Anesthesiology and Intensive Care Medicine
- Principal Investigator Name
- Peter Rosenberger
- Principal Investigator Email
- peter.rosenberger@medizin.uni-tuebingen.de
- Contact Person Name
- Peter Rosenberger
- Contact Person Email
- peter.rosenberger@medizin.uni-tuebingen.de
- Site Name
- Universitaet Muenster
- Department Name
- Department of Anesthesiology, Intensive Care and Pain Medicine
- Principal Investigator Name
- Alexander Zarbock
- Principal Investigator Email
- zarbock@uni-muenster.de
- Contact Person Name
- Alexander Zarbock
- Contact Person Email
- zarbock@uni-muenster.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Thorax- und Kardiovaskuläre Chirurgie, Westdeutsches Herz- und Gefässzentrum Essen
- Principal Investigator Name
- Matthias Thielmann
- Principal Investigator Email
- Matthias.Thielmann@uk-essen.de
- Contact Person Name
- Matthias Thielmann
- Contact Person Email
- Matthias.Thielmann@uk-essen.de
- Site Name
- Justus-Liebig-Universitaet Giessen
- Department Name
- Klinik für Herz-, Kinderherz- und Gefäßchirurgie
- Principal Investigator Name
- Andreas Böning
- Principal Investigator Email
- Andreas.Boening@chiru.med.uni-giessen.de
- Contact Person Name
- Andreas Böning
- Contact Person Email
- Andreas.Boening@chiru.med.uni-giessen.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Deutsches Herzzentrum der Charité - Klinik für Kardioanästhesiologie und Intensivmedizin
- Principal Investigator Name
- Christian Stoppe
- Principal Investigator Email
- christian.stoppe@charite-dhzc.de
- Contact Person Name
- Christian Stoppe
- Contact Person Email
- christian.stoppe@charite-dhzc.de
- Site Name
- Universitaetsklinikum Augsburg
- Department Name
- Department of Anesthesiology and Intensive Care Medicine
- Principal Investigator Name
- Philipp Simon
- Principal Investigator Email
- Philipp.Simon3@uk-augsburg.de
- Contact Person Name
- Philipp Simon
- Contact Person Email
- Philipp.Simon3@uk-augsburg.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Department of Anesthesiology
- Principal Investigator Name
- Eva Wittenmeier
- Principal Investigator Email
- Eva.Wittenmeier@unimedizin-mainz.de
- Contact Person Name
- Eva Wittenmeier
- Contact Person Email
- Eva.Wittenmeier@unimedizin-mainz.de
Sponsor
Primary sponsor
- Full Name
- Universitaet Muenster
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Germany
Third parties
- {"country":"","full_name":"PAION Deutschland GmbH","duties_or_roles":"Monetary support","organisation_type":""}
- {"country":"","full_name":"Deutsche Forschungsgemeinschaft","duties_or_roles":"Monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- Giapreza 2.5 mg/ml concentrate for solution for infusion
- Active Substance
- Angiotensin II
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation EU/1/19/1384/003)
- Starting Dose
- 0.01 mg/ml (infusion bag containing Angiotensin II 0.01 mg/ml)
- Maximum Dose
- 64.8 µg/Kg daily; max total 180 µg/Kg
- Investigational Product Name
- NOREPINEPHRINE
- Active Substance
- Noradrenaline tartrate
- Modality
- Small molecule
- Routes Of Administration
- Intravenous perfusion
- Route
- Intravenous perfusion
- Starting Dose
- 0.1 mg/ml (infusion bag containing Norephinephrin 0.1 mg/ml)
- Maximum Dose
- 4.3 mg/kg daily; max total 13 mg/kg
Related trials
Other published trials that may interest you.
- Colchicine (also listed with opium standardized powdered and tiemonium methylsulphate in product record) for Chronic kidney disease (moderate) | Cardiovascular disease (secondary prevention)
- SODIUM HYDROGEN CARBONATE for Metabolic acidosis|Acute kidney injury|Critical illness
- GD2IL18CART for Neuroblastoma | Osteosarcoma | Ewing sarcoma | Advanced breast cancer
- TESTOSTERONE for Metastatic castration-resistant prostate cancer
- TTF-NGR for Soft tissue sarcoma | Leiomyosarcoma | Liposarcoma | Rhabdomyosarcoma | Angiosarcoma | Synovial sarcoma | Undifferentiated sarcoma | Myxofibrosarcoma | Dedifferentiated liposarcoma | Myxoid liposarcoma | Pleomorphic liposarcoma