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PERSONALISATION OF IMMUNOSUPPRESSION BY MONITORING VIRAL LOAD POST KIDNEY TRANSPLANTATION - A RANDOMISED CONTROLLED PHASE II TRIAL

Objective

Challenge: End stage renal disease (ESRD) causes high socioeconomic burden for citizens and the healthcare system in Europe. Kidney transplantation represents the treatment standard for ESRD. Graft rejection due to inadequate immunosuppression is the leading cause for chronic graft dysfunction and infectious disease due to reduced immune function is a major cause of death. Optimisation of immunosuppressive drugs is a crucial step to minimize the risk of infection and rejection and thereby prolonging patient and graft survival.

Background: The peripheral blood copy number of the highly prevalent and non-pathogenic Torque Teno virus (TTV) is associated with the grade of the immunosuppression of the host. Non-interventional studies suggest superiority of TTV copy number guided immunosuppression compared to standard strategies.

Objectives: To demonstrate the safety and preliminary efficacy of TTV-guided dosing of immunosuppressive drugs in kidney transplant recipients.

Method: A phase II clinical trial comparing infection and rejection rate between TTV-guided immunosuppression and the clinical routine strategy.

Ambition: TTV allows for a comprehensive and personalised assessment of the function of the immune system. For the first time this novel and original approach will be tested in an interventional randomised and controlled setting.

Impact: The proposed project has the potential to reduce infection and graft rejection by 20% thereby significantly improving graft and patient survival of kidney transplant patients. The improved survival will reduce healthcare costs by ~€ 50 million in the EU per year. The project will serve as a proof-of-concept for TTV-based assessment of the immune system, with potential applications in solid organ transplantation, autoimmune and infectious disease and oncology.

Field of science

  • /medical and health sciences/clinical medicine/transplantation
  • /medical and health sciences/basic medicine/immunology
  • /medical and health sciences/clinical medicine/nephrology

Call for proposal

H2020-SC1-2020-Two-Stage-RTD
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

MEDIZINISCHE UNIVERSITAET WIEN
Address
Spitalgasse 23
1090 Wien
Austria
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 973 306,25

Participants (18)

BIOMERIEUX SA
France
EU contribution
€ 801 750
Address
Chemin De L'orme
69280 Marcy L'etoile
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EUTEMA RESEARCH SERVICES GMBH
Austria
EU contribution
€ 435 750
Address
Karl Toldt Weg 6D
1140 Vienna
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
EU contribution
€ 135 996
Address
5 Rue Watt
75013 Paris
Activity type
Research Organisations
MEDIZINISCHE UNIVERSITAT INNSBRUCK
Austria
EU contribution
€ 288 750
Address
Christoph Probst Platz 1
6020 Innsbruck
Activity type
Higher or Secondary Education Establishments
MEDIZINISCHE UNIVERSITAT GRAZ
Austria
EU contribution
€ 191 562,50
Address
Auenbruggerplatz 2
8036 Graz
Activity type
Higher or Secondary Education Establishments
ORDENSKLINIKUM LINZ GMBH
Austria
EU contribution
€ 191 562,50
Address
Harrachstrasse 17
4020 Linz
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
TECHNISCHE UNIVERSITAET DRESDEN
Germany
EU contribution
€ 722 268,75
Address
Helmholtzstrasse 10
01069 Dresden
Activity type
Higher or Secondary Education Establishments
KLINIKUM DER UNIVERSITAET REGENSBURG
Germany
EU contribution
€ 206 562,50
Address
Frans Josef Strauss Allee 11
93053 Regensburg
Activity type
Higher or Secondary Education Establishments
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany
EU contribution
€ 191 562,50
Address
Chariteplatz 1
10117 Berlin
Activity type
Higher or Secondary Education Establishments
Institut klinické a experimentální mediciny
Czechia
EU contribution
€ 288 750
Address
Videnska 1958/9
14021 Prague 4
Activity type
Research Organisations
FUNDACION PARA LA INVESTIGACION DEL HOSPITAL UNIVERSITARIO LA FE DE LA COMUNIDAD VALENCIANA
Spain
EU contribution
€ 129 062,50
Address
Av Fernando Abril Martorell 106
46026 Valencia
Activity type
Research Organisations
FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA
Spain
EU contribution
€ 85 625
Address
Av Menendez Pelayo 4
46010 Valencia
Activity type
Research Organisations
CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE
France
EU contribution
€ 236 760
Address
Boulevard De La Chantourne
38700 La Tronche
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
HOPITAUX UNIVERSITAIRES DE STRASBOURG
France
EU contribution
€ 191 562,50
Address
Place De L Hopital 1
67091 Strasbourg Cedex
Activity type
Research Organisations
UNIVERSITA DI PISA
Italy
EU contribution
€ 137 125
Address
Lungarno Pacinotti 43/44
56126 Pisa
Activity type
Higher or Secondary Education Establishments
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
EU contribution
€ 303 750
Address
Albinusdreef 2
2333 ZA Leiden
Activity type
Higher or Secondary Education Establishments
ACADEMISCH ZIEKENHUIS GRONINGEN
Netherlands
EU contribution
€ 393 437,50
Address
Hanzeplein 1
9713 GZ Groningen
Activity type
Higher or Secondary Education Establishments
UNIVERSIDAD DE GRANADA
Spain
EU contribution
€ 194 687,50
Address
Cuesta Del Hospicio Sn
18071 Granada
Activity type
Higher or Secondary Education Establishments