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MedUni Vienna successfully submits first multicentre clinical trial to European CTIS information system

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(Vienna, 12 September 2022) Within the framework of the EU Horizon 2020 project "TTV GUIDE TX", MedUni Vienna was the first academic institution in Austria to submit a clinical trial to the Clinical Trials Information System (CTIS) under Europe’s new harmonised Clinical Trials Regulation (Regulation (EU) 536/2014). The project is investigating the management of immunosuppressive treatment following a kidney transplant by measuring levels of TT virus.

The Clinical Trials Regulation (CTR) has harmonised the procedures for evaluating and monitoring multinational clinical trials within the EU area since 2022. Online applications for approval to conduct a clinical trial in multiple European countries are submitted through a single online platform known as the Clinical Trials Information System (CTIS), thus improving efficiency in conducting such multinational trials.

TT virus as an indicator for immunosuppressants
The TTV GUIDE TX project was developed to optimise the management of immunosuppressive treatment. Kidney transplant recipients need to take immunosuppressants to reduce the risk of organ rejection. However, because their immune system is weakened, they are at greater risk of contracting infections. Immunosuppressants, especially calcineurin inhibitors, are currently dosed primarily on the basis of drug levels in the blood, even though this measurement does not adequately reflect the degree of immunosuppression.

This project aims to use the quantification of the harmless Torque Teno Virus (TTV), which is present in most humans, to optimise immunosuppression after kidney transplantation and thus reduce the probability of organ rejection and infections. TTV occurs naturally in the blood of healthy individuals and kidney transplant recipients without causing disease. If the patient's immune system is strong, the TTV load is low, indicating a risk of organ rejection. If their immune system is weak, the TTV load is high, indicating a risk of infection.

TTV is therefore quantified in the blood of kidney transplant recipients using a PCR test. In preliminary work carried out by the working group led by Gregor Bond (Division of Nephrology and Dialysis), in collaboration with MedUni Vienna's Center for Virology (Elisabeth Puchhammer-Stöckl) and the virology section of the Department of Laboratory Medicine (Robert Strassl), scientists were able to define a TTV range that is representative of optimal immunosuppression. Fundamental preliminary work was also done by the Department of Thoracic Surgery (Peter Jaksch).
In the clinical trial conducted as part of the TTV GUIDE TX project, more than 260 kidney transplant recipients from 13 centres in six countries are randomised to receive immunosuppressive treatment managed either on the basis of the conventional strategy - calcineurin inhibitor trough level - or levels of TTV in the blood.

The European Union's Horizon 2020 Health Call is funding the project (project number 896932) with a total of more than €6 million over five years. Gregor Bond from MedUni Vienna's Division of Nephrology and Dialysis is Chief Investigator and coordinator of the project with a total of 19 partners from seven European countries.

About the Clinical Trials Regulation (CTR)
Since 2022, the Clinical Trials Regulation harmonises the procedures for evaluating and monitoring clinical trials on a multinational level within the EU. Evaluation, approval and monitoring of clinical trials are the responsibility of EU Member States and European Economic Area (EEA) countries. Prior to this regulation, clinical trial applicants had to submit separate applications to the relevant national authorities and ethics committees of each individual country in order to obtain regulatory approval to conduct a clinical trial. The regulation allows applicants to submit an online application through a single online platform know as the Clinical Trials Information System (CTIS) for approval to conduct a clinical trial in multiple European countries, thus improving efficiency in conducting such multinational trials. The regulation also makes it more efficient for EU member states to jointly evaluate and approve such applications via the Clinical Trials Information System.

The aim is to promote innovation and research in the EU and to facilitate the conduct of larger-scale clinical trials in multiple EU member states/EEA countries. In Austria, the application is evaluated and approved by the Agency for Health and Food Safety (AGES) on behalf of the Federal Office for Safety in Health Care (BASG), together with the relevant ethics committee.

This was the first clinical trial that Austria has overseen as a Reporting Member State (RMS). The RMS has the specific task of preparing all the expert opinions required by law, which then only need to be commented on by the other participating states. Austria was chosen by the sponsor of the multinational study, because the AGES was already familiar with the TTV Guide TX project from innovation discussions held to promote novel study approaches. This experience not only qualified Austria as an RMS but also allowed the assessment to be completed efficiently and without any critical deficiencies or delays.