Clinical trial • Phase II • Infectious Disease|Nephrology

TIN816 for Sepsis-associated acute kidney injury|Acute kidney injury|Sepsis

Phase II trial of TIN816 for Sepsis-associated acute kidney injury|Acute kidney injury|Sepsis.

Overview

Trial Therapeutic Area
Infectious Disease|Nephrology
Trial Disease
Sepsis-associated acute kidney injury|Acute kidney injury|Sepsis
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
25-01-2024
First CTIS Authorization Date
08-05-2024

Trial design

Randomised, placebo: sterile 0.9% sodium chloride solution for infusion will be administered as placebo to participants randomized to the placebo treatment. the solution is ready to use in a 100ml infusion bag of 0.9% sodium chloride solution.-controlled Phase II trial in Germany, Czechia, Austria and others.

Randomised
Yes
Comparator
Placebo: Sterile 0.9% sodium chloride solution for infusion will be administered as placebo to participants randomized to the placebo treatment. The solution is ready to use in a 100mL infusion bag of 0.9% sodium chloride solution.
Target Sample Size
201
Trial Duration For Participant
90

Eligibility

Recruits 201 The trial includes critically ill participants admitted to ICU/HDU (vulnerable population). Consent materials for legally authorised representatives/parent/legal guardian are provided (e.g. documents titled 'Parent Legal Guardian', 'Info Sheet trusted person' appear in the submission). Where participants are unable to consent, consent from a legal representative/trusted person is indicated by the presence of these documents..

Vulnerable Population
The trial includes critically ill participants admitted to ICU/HDU (vulnerable population). Consent materials for legally authorised representatives/parent/legal guardian are provided (e.g. documents titled 'Parent Legal Guardian', 'Info Sheet trusted person' appear in the submission). Where participants are unable to consent, consent from a legal representative/trusted person is indicated by the presence of these documents.

Inclusion criteria

  • {"criterion_text":"-1.\t≥ 18 to ≤ 85 years of age\n-2.\tAdmitted to ICU or intermediate care unit/ high dependency care unit (HDU)\n-3.\tDiagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on: -Suspected or confirmed infection AND - Acute increase of SOFA score of 2 or more (excluding renal component). The baseline SOFA score should be assumed to be zero unless the patients known to have pre-existing (acute or chronic) organ dysfunction before the onset of infection.\n-4.\tDiagnosis of AKI Stage 1 or greater per the following criterion at randomization: An absolute increase in serum or plasma creatinine by ≥ 0.3 mg/dL (≥ 26.5 µmol/L) within 48 hours or presumed to have occurred in the previous 48 hours as compared to the reference pre-sepsis creatinine. •\tFor patients with hospital-acquired AKI, a stable serum creatinine obtained in the hospital prior to AKI diagnosis should be used as the reference serum creatinine. •\tFor patients presenting from community, the reference pre-sepsis serum creatinine should be estimated using the following order of preference: 1. The most recent value within 3 months of the hospital admission. If not available: 2. The most recent value between 3 and 12 months prior to hospital admission. If not available: 3. At hospital admission"}

Exclusion criteria

  • {"criterion_text":"-3.\t3.\tHistory of CKD with a documented estimated GFR < 30 ml/min prior to admission to hospital\n-16.\tPatients who are thrombocytopenic at screening (platelet count <50,000 per microliter) or other high risk for bleeding in the opinion of the investigator.\n-4.\teGFR <45ml/min at admission without any other reference serum eGFR within last 12-months\n-5.\tReceiving RRT or a decision has been made to initiate RRT within 24 hours after randomization.\n-8.\tSepsis diagnosis according to sepsis inclusion criteria for a period longer than 72 hours prior to ICU admission.\n-9.\tAKI diagnosis according to AKI inclusion criteria over 48 hours after admission to ICU.\n-10.\tInability to administer study drug within 24 hours of diagnosis of AKI according to AKI inclusion criteria.\n-11.\tPresence of AKI, in the Investigator's opinion, as suggested by clinical manifestation, e.g., prolonged oliguria or severe renal dysfunction on admission without a history of CKD, for a period longer than 24 hours prior to study drug administration.\n-12.\tEvidence of recovery from AKI based on the investigator’s clinical judgement prior to randomization.\n-14.\tDocumented (biopsy proven) or suspected history of acute or sub-acute kidney diseases such as rapidly progressive glomerular nephritis (RPGN) and acute interstitial nephritis (AIN)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-The weighted average of area under the time-corrected endogenous creatinine clearance curve from Day 1 to Day 8 (AUC1-8).","definition_or_measurement_approach":"Renal function measured by endogenous creatinine clearance; primary endpoint is the weighted average area under the time-corrected endogenous creatinine clearance curve from Day 1 to Day 8 (AUC1-8)."}

Secondary endpoints

  • {"endpoint_text":"-Composite endpoint of major adverse kidney events (MAKE) including death, use of RRT and ≥25% reduction from reference in eGFR at Day 90","definition_or_measurement_approach":"Composite MAKE at Day 90: includes death, use of renal replacement therapy (RRT), and ≥25% reduction in eGFR from reference."}
  • {"endpoint_text":"-The weighted average of area under the time-corrected endogenous serum creatinine and endogenous serum cystatin C curve from Day1 to Day14 and Day1 to Day30 The weighted average of area under the time-corrected endogenous creatinine clearance curve from Day5 to Day14 (AUC5-14). Any use of RRT during the study RRT dependency at Day90 Days alive and free of RRT at Day90 Proportion of participants with eGFR decline ≥25% from reference at Day90 Change of KDIGO AKI stage from baseline at Day14.","definition_or_measurement_approach":"Multiple measures: weighted AUCs for serum creatinine and cystatin C (D1-D14 and D1-D30), AUC5-14 for creatinine clearance, any use of RRT during study, RRT dependency at Day90, days alive and free of RRT at Day90, proportion with ≥25% eGFR decline at Day90, change in KDIGO AKI stage at Day14."}
  • {"endpoint_text":"-Change of sequential organ failure assessment (SOFA) score from baseline to Day 30","definition_or_measurement_approach":"Change in SOFA score from baseline to Day 30."}
  • {"endpoint_text":"-Adverse events and serious adverse events","definition_or_measurement_approach":"Collection and reporting of adverse events (AEs) and serious adverse events (SAEs) during the study."}

Recruitment

Planned Sample Size
201
Recruitment Window Months
17
Consent Approach
Informed consent is documented via country-specific ICFs (Main ICF - Adult). Consent materials include adult ICFs and documents for legal representatives/parent legal guardian and trusted persons, and separate data protection consent forms. ICFs are provided in multiple languages (see below); when participants are unable to consent (ICU setting), consent/authorization from a legal representative or trusted person is indicated by the presence of Parent/Legal Guardian and 'Info Sheet trusted person' documents.

Geography

Total Number Of Sites
55
Total Number Of Participants
138

Germany

Earliest CTIS Part Ii Submission Date
08-03-2024
Latest Decision Or Authorization Date
25-09-2025
Processing Time Days
566
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Goethe University Frankfurt
Department Name
#3401: Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie
Principal Investigator Name
Kai Zacharowski
Principal Investigator Email
kai.zacharowski@kgu.de
Contact Person Name
Kai Zacharowski
Contact Person Email
kai.zacharowski@kgu.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
#3402: Klinik für Anästhesiologie und Intensivmedizin
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
Klinikum der Universitaet Muenchen AöR
Department Name
#3409: Klinik für Allgemein-, Viszeral-, und Transplantationschirurgie
Principal Investigator Name
Michael Neuberger
Principal Investigator Email
Michael.Neuberger@med.uni-muenchen.de
Contact Person Name
Michael Neuberger
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
#3405: I. Medizinische Klinik und Poliklinik
Principal Investigator Name
Julia Weinmann-Menke
Principal Investigator Email
Julia.weinmann-menke@unimedizin-mainz.de
Contact Person Name
Julia Weinmann-Menke
Site Name
Universitaet Muenster
Department Name
#3411:Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
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
Robert-Bosch-Krankenhaus GmbH
Department Name
#3410: Abteilung fuer Allgemeine Innere Medizin und Nephrologie
Principal Investigator Name
Joerg Latus
Principal Investigator Email
Joerg.latus@rbk.de
Contact Person Name
Joerg Latus
Contact Person Email
Joerg.latus@rbk.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
#3408: Klinik für Anästhesiologie und Intensivmedizin
Principal Investigator Name
Thorsten Brenner
Principal Investigator Email
Thorsten.brenner@uk-essen.de
Contact Person Name
Thorsten Brenner
Contact Person Email
Thorsten.brenner@uk-essen.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
#3400: Klinik für Anästhesiologie und Operative Intensivmedizin
Principal Investigator Name
Dirk Schädler
Principal Investigator Email
dirk.schaedler@uksh.de
Contact Person Name
Dirk Schädler
Contact Person Email
dirk.schaedler@uksh.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
#3403: Klinik fuer Anaesthesiologie
Principal Investigator Name
Sebastian Decker
Principal Investigator Email
Sebastian.decker@med.uni-heidelberg.de
Contact Person Name
Sebastian Decker

Czechia

Earliest CTIS Part Ii Submission Date
17-04-2024
Latest Decision Or Authorization Date
21-03-2025
Processing Time Days
338
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
#3203: III. Interni Gerontometabolicka klinika
Principal Investigator Name
Jan Maňák
Principal Investigator Email
jan.manak@fnhk.cz
Contact Person Name
Jan Maňák
Contact Person Email
jan.manak@fnhk.cz
Site Name
Oblastni nemocnice Kolin a.s. nemocnice Stredoceskeho kraje
Department Name
#3200: Resuscitační odd.a Víceoborová JIP
Principal Investigator Name
Martin Nováček
Principal Investigator Email
martin.novacek@nemocnicekolin.cz
Contact Person Name
Martin Nováček
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
#3201: Anesteziologicko-resuscitační oddělení
Principal Investigator Name
Vladimír Šrámek
Principal Investigator Email
vladimir.sramek@fnusa.cz
Contact Person Name
Vladimír Šrámek
Contact Person Email
vladimir.sramek@fnusa.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
#3202: Klinika anesteziologie a resuscitace
Principal Investigator Name
František Duška
Principal Investigator Email
frantisek.duska@lf3.cuni.cz
Contact Person Name
František Duška
Contact Person Email
frantisek.duska@lf3.cuni.cz

Austria

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
529
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Univ. Klinik f. Anaesthesie u. Intensivmedizin
Principal Investigator Name
Dietmar Fries
Principal Investigator Email
dietmar.fries@tirol-kliniken.at
Contact Person Name
Dietmar Fries
Site Name
Medizinische Universitaet Innsbruck
Department Name
Univ. Klinik f. Innere Medizin I Intensiv- und Notfallmedizin
Principal Investigator Name
Michael Joannidis
Principal Investigator Email
michael.joannidis@i-med.ac.at
Contact Person Name
Michael Joannidis
Contact Person Email
michael.joannidis@i-med.ac.at

Spain

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
529
Number Of Sites
11
Number Of Participants
20

Sites

Site Name
Hospital De Jerez De La Frontera
Department Name
#3810:UCI/medicina intensiva
Principal Investigator Name
Ángel Estella García
Principal Investigator Email
angel.estella@gm.uca.es
Contact Person Name
Ángel Estella García
Contact Person Email
angel.estella@gm.uca.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
#3804:UCI/medicina intensiva
Principal Investigator Name
Ignacio Saéz de la Fuente
Principal Investigator Email
Ignacio.saez@salud.madrid.org
Contact Person Name
Ignacio Saéz de la Fuente
Contact Person Email
Ignacio.saez@salud.madrid.org
Site Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Department Name
#3802:UCI/medicina intensiva
Principal Investigator Name
Enrique Piacentini Gómez
Principal Investigator Email
epiacentini@mutuaterrassa.es
Contact Person Name
Enrique Piacentini Gómez
Contact Person Email
epiacentini@mutuaterrassa.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
#3809:UCI/medicina intensiva
Principal Investigator Name
María Jesús Broch Porcar
Principal Investigator Email
broch_mje@gva.es
Contact Person Name
María Jesús Broch Porcar
Contact Person Email
broch_mje@gva.es
Site Name
Bellvitge University Hospital
Department Name
#3808:UCI/medicina intensiva
Principal Investigator Name
Joan Sabater Riera
Principal Investigator Email
jsabater@bellvitgehospital.cat
Contact Person Name
Joan Sabater Riera
Contact Person Email
jsabater@bellvitgehospital.cat
Site Name
Parc Tauli Hospital Universitari
Department Name
#3807:UCI/medicina intensiva
Principal Investigator Name
Ana Navas Pérez
Principal Investigator Email
anavas@tauli.cat
Contact Person Name
Ana Navas Pérez
Contact Person Email
anavas@tauli.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
#3801:UCI/medicina intensiva
Principal Investigator Name
Ricard Ferrer Roca
Principal Investigator Email
ricard.ferrer@vallhebron.cat
Contact Person Name
Ricard Ferrer Roca
Contact Person Email
ricard.ferrer@vallhebron.cat
Site Name
Hospital General Universitario Reina Sofia
Department Name
#3807:UCI/medicina intensiva
Principal Investigator Name
Carmen de la Fuente Martos
Principal Investigator Email
carmen.fuente.sspa@juntadeandalucia.es
Contact Person Name
Carmen de la Fuente Martos
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
#3806:UCI/medicina intensiva
Principal Investigator Name
Pedro Alberto Rascado Sede
Principal Investigator Email
pedro.rascado.sedes@sergas.es
Contact Person Name
Pedro Alberto Rascado Sede
Contact Person Email
pedro.rascado.sedes@sergas.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
#3800:UCI/medicina intensiva
Principal Investigator Name
Antoni Jordi Betbesé Roig
Principal Investigator Email
abetbese@santpau.cat
Contact Person Name
Antoni Jordi Betbesé Roig
Contact Person Email
abetbese@santpau.cat
Site Name
Hospital Clinico San Carlos
Department Name
#3811: UCI/medicina intensiva
Principal Investigator Name
Fernando Martínez Sagasti
Principal Investigator Email
fernando.martinez@salud.madrid.org
Contact Person Name
Fernando Martínez Sagasti

Hungary

Earliest CTIS Part Ii Submission Date
16-04-2024
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
531
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name
#3503: Központi Aneszteziológiai és Intenzív Betegellátó Osztály, Szent István Telephely, D ép.
Principal Investigator Name
Ilona Bobek
Principal Investigator Email
bobekilona@dpckorhaz.hu
Contact Person Name
Ilona Bobek
Contact Person Email
bobekilona@dpckorhaz.hu
Site Name
University Of Debrecen
Department Name
#3501: Belgyógyászati Klinika, A épület
Principal Investigator Name
György Kerekes
Principal Investigator Email
gkerekesg@gmail.com
Contact Person Name
György Kerekes
Contact Person Email
gkerekesg@gmail.com
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
#3500: Központi Aneszteziológia és Intenzív Betegellátó Osztály
Principal Investigator Name
Ágnes Sárkány
Principal Investigator Email
asarkany@mail.fmkorhaz.hu
Contact Person Name
Ágnes Sárkány
Contact Person Email
asarkany@mail.fmkorhaz.hu
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
#3504:Központi Aneszteziológiai és Intenzív Betegellátó Osztály
Principal Investigator Name
Csaba Hermann
Principal Investigator Email
hermann.csaba.gyula@ga.sze.hu
Contact Person Name
Csaba Hermann
Contact Person Email
hermann.csaba.gyula@ga.sze.hu

Italy

Earliest CTIS Part Ii Submission Date
20-03-2024
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
734
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Humanitas Research Hospital
Department Name
#3603: UO Anestesia e Terapia Intensiva Generale
Principal Investigator Name
Maurizio Cecconi
Principal Investigator Email
maurizio.cecconi@hunimed.eu
Contact Person Name
Maurizio Cecconi
Contact Person Email
maurizio.cecconi@hunimed.eu
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
#3600: U.O.C. Malattie Infettive
Principal Investigator Name
Pierluigi Viale
Principal Investigator Email
pierluigi.viale@unibo.it
Contact Person Name
Pierluigi Viale
Contact Person Email
pierluigi.viale@unibo.it
Site Name
Azienda Ospedaliera Ospedale Niguarda Ca Granda
Department Name
#3604: SC Malattie Infettive
Principal Investigator Name
Marco Merli
Principal Investigator Email
marco.merli@ospedaleniguarda.it
Contact Person Name
Marco Merli
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
#3608: UOC Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica
Principal Investigator Name
Massimo Antonelli
Principal Investigator Email
massimo.antonelli@policlinicogemelli.it
Contact Person Name
Massimo Antonelli
Site Name
ASST Fatebenefratelli Sacco
Department Name
#3607: S.C. Malattie Infettive 2
Principal Investigator Name
Andrea Gori
Principal Investigator Email
andrea.gori@unimi.it
Contact Person Name
Andrea Gori
Contact Person Email
andrea.gori@unimi.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
#3601: UOC Malattie Infettive
Principal Investigator Name
Ivan Gentile
Principal Investigator Email
ivan.gentile@unina.it
Contact Person Name
Ivan Gentile
Contact Person Email
ivan.gentile@unina.it
Site Name
Azienda Ospedale-Universita Padova
Department Name
#3606: U.O.C. Istituto Anestesia e Rianimazione
Principal Investigator Name
Annalisa Boscolo Bozza
Principal Investigator Email
Ist.anestesia.rianimaz@aopd.veneto.it
Contact Person Name
Annalisa Boscolo Bozza

France

Earliest CTIS Part Ii Submission Date
25-03-2024
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
724
Number Of Sites
12
Number Of Participants
20

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
#3305:Medical Intensive Care Unit
Principal Investigator Name
Xavier Monnet
Principal Investigator Email
xavier.monnet@aphp.fr
Contact Person Name
Xavier Monnet
Contact Person Email
xavier.monnet@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
#3314: Intensive care Unit
Principal Investigator Name
Céline Monard
Principal Investigator Email
celine.monard@chu-lyon.fr
Contact Person Name
Céline Monard
Contact Person Email
celine.monard@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
#3300:Department of Nephrology and organs transplantation
Principal Investigator Name
Stanislas Faguer
Principal Investigator Email
faguer.s@chu-toulouse.fr
Contact Person Name
Stanislas Faguer
Contact Person Email
faguer.s@chu-toulouse.fr
Site Name
Centre Hospitalier Victor Dupouy
Department Name
#3307:Department of Intensive Care
Principal Investigator Name
Gaëtan Plantefeve
Principal Investigator Email
gaetan.plantefeve@ch-argenteuil.fr
Contact Person Name
Gaëtan Plantefeve
Site Name
Assistance Publique Hopitaux De Paris
Department Name
#3309:Intensive care unit
Principal Investigator Name
Nicholas HEMING
Principal Investigator Email
Nicholas.heming@aphp.fr
Contact Person Name
Nicholas HEMING
Contact Person Email
Nicholas.heming@aphp.fr
Site Name
Centre Hospitalier Universitaire D Angers
Department Name
#3311: Intensive care Unit
Principal Investigator Name
Pierre Asfar
Principal Investigator Email
piasfar@chu-angers.fr
Contact Person Name
Pierre Asfar
Contact Person Email
piasfar@chu-angers.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
#3306:Anesthesiology and Critical Care departments
Principal Investigator Name
Antoine DEWITTE
Principal Investigator Email
antoine.dewitte@chu-bordeaux.fr
Contact Person Name
Antoine DEWITTE
Site Name
Centre Hospitalier Regional De Marseille
Department Name
#3313:Intensive care Unit
Principal Investigator Name
Florence Daviet
Principal Investigator Email
florence.daviet@ap-hm.fr
Contact Person Name
Florence Daviet
Contact Person Email
florence.daviet@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
#3308:Intensive care Unit
Principal Investigator Name
Jérémie Lemarié
Principal Investigator Email
jeremie.lemarie@chu-nantes.fr
Contact Person Name
Jérémie Lemarié
Contact Person Email
jeremie.lemarie@chu-nantes.fr
Site Name
Alentis Development
Department Name
#3301:Department of intensive care Medicine
Principal Investigator Name
Ferhat Meziani
Principal Investigator Email
Ferhat.meziani@chru-strasbourg.fr
Contact Person Name
Ferhat Meziani
Site Name
Assistance Publique Hopitaux De Paris
Department Name
#3302:Department of Anesthesiology and critical care medicine
Principal Investigator Name
Benjamin Chousterman
Principal Investigator Email
Benjamin.chousterman@aphp.fr
Contact Person Name
Benjamin Chousterman
Contact Person Email
Benjamin.chousterman@aphp.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
#3310:Intensive care Unit
Principal Investigator Name
Anne-Laure Fedou
Principal Investigator Email
Anne-Laure.fedou@chu-limoges.fr
Contact Person Name
Anne-Laure Fedou

Belgium

Earliest CTIS Part Ii Submission Date
19-04-2024
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
705
Number Of Sites
4
Number Of Participants
49

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
#3102: Intensive Care
Principal Investigator Name
Alexis Wérion
Principal Investigator Email
alexis.werion@saintluc.uclouvain.be
Contact Person Name
Alexis Wérion
Site Name
Clinique Saint-Pierre
Department Name
#3101: Intensive Care
Principal Investigator Name
Nicolas De Schryver
Principal Investigator Email
nicolas.deschryver@cspo.be
Contact Person Name
Nicolas De Schryver
Contact Person Email
nicolas.deschryver@cspo.be
Site Name
Universitair Ziekenhuis Gent
Department Name
#3103: Intensive Care
Principal Investigator Name
Eric Hoste
Principal Investigator Email
Eric.hoste@uzgent.be
Contact Person Name
Eric Hoste
Contact Person Email
Eric.hoste@uzgent.be
Site Name
Ziekenhuis Oost Limburg
Department Name
#3100: Anesthesiology – Intensive Care
Principal Investigator Name
Tom Fivez
Principal Investigator Email
Tom.Fivez@zol.be
Contact Person Name
Tom Fivez
Contact Person Email
Tom.Fivez@zol.be

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Name
Parexel International (IRL) Limited
Name
Parexel (as listed)
Name
Syneos Health Inc.
Name
Icon Clinical Research Limited
Name
Iqvia Rds Inc.
Responsibilities
1) Randomization of Patients. 2) Management of drug supply logistics, dispensing and unblinding.
Name
Medpace Inc.
Responsibilities
Clinical Chemistry and haematology

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Somalogic Operating Co. Inc.","duties_or_roles":"Protein Profiling (Plasma)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"Opt-X-Pense Kft.","duties_or_roles":"patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Patients guides and tools","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"PRO formatting and translations","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"DATAMAP-Gesellschaft fuer Datenmanagement Datenanalyse und Datenpraesentation mbH","duties_or_roles":"Independent statistical group for Data Monitoring Committee (DMC) and Interim Analysis (IA)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Kayentis","duties_or_roles":"PRO management, PRO licensing and translations, data collection via tablet.","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Hungary","full_name":"ADR Logistics Kft.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Immunogenicity analyses","organisation_type":"Pharmaceutical company"}
  • {"country":"Austria","full_name":"Mag. Andreas Raffeiner GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"Mobile Nursing","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"Distribution and Destruction IMP. Re-labelling IMP Sterile 0.9% sodium chloride solution","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medpace Inc.","duties_or_roles":"Clinical Chemistry and haematology","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"SGS France","duties_or_roles":"Immunogenicity analyses and Biomarker Analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Lonza AG","duties_or_roles":"Study drug manufacturing","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Eurofins Central Laboratory B.V.","duties_or_roles":"Biomarkers IL-18, IL-1Beta (Urine)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Clinical payment automation for participant travel and accommodation.","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"1) Randomization of Patients. 2) Management of drug supply logistics, dispensing and unblinding.","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"Pharmacokinetic and Immunogenicity analyses","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"SGS Analytics Switzerland AG","duties_or_roles":"Pharmacokinetic analyses","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
TIN816
Active Substance
TIN816
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Frequency
Single intravenous infusion
Maximum Dose
4.0 mg/kg
Investigational Product Name
Sterile 0.9% sodium chloride solution for infusion will be administered as placebo to participants randomized to the placebo treatment. The solution is ready to use in a 100mL infusion bag of 0.9% sodium chloride solution
Modality
Other

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