Project description
New method to personalise immunosuppression in kidney transplants
Kidney transplantation represents the treatment standard for end-stage renal disease. 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 crucial to minimising the risk of infection and rejection and thereby prolonging patient and graft survival. The peripheral blood copy number of the 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. EU-funded TTV GUIDE TX will test safety and preliminary efficacy of TTV-guided immunosuppression within a phase II randomised and controlled clinical 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.
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Funding Scheme
RIA - Research and Innovation actionCoordinator
1090 Wien
Austria
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Participants (21)
69280 Marcy l'Etoile
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1140 Wien
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
75014 Paris
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
601 77 Brno
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
6020 Innsbruck
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8010 Graz
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4020 Linz
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01069 Dresden
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93053 Regensburg
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10117 Berlin
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14021 Prague 4
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46026 Valencia
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46010 Valencia
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38700 La Tronche
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67091 Strasbourg Cedex
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56126 Pisa
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2333 ZA Leiden
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9713 GZ Groningen
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18071 Granada
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Participation ended
21100 Varese
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00149 Roma
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