The TRANSBIO clinical study has started with inclusion of the first patient in the Hospital Puerta de Hierro (Madrid, Spain) on the 12th of June 2018, with Dr. José María Portoles as Principal Investigator. The University Hospital Puerta de Hierro was created in 1964 and it is a general hospital of first level that fulfils a triple function: assistance, teaching and research.
This multi-centre international study has 8 participating hospitals from 5 different countries and will recruit a total of 200 patients. The centres involved in the TRANSBIO clinical study are the University Hospital, Hospital del Mar and Hospital Vall’d Hebron (Barcelona, Spain); the Hospital Puerta de Hierro and Hospital La Paz (Madrid, Spain); the RigsHospitalet (Copenhague, Denmark); the Universitätsklinikum Essen (Germany); the University Hospital Borowska (Wroclaw, Poland) and the Massachusetts General Hospital (Boston, USA).
The clinical and immunological history collected during the clinical study together with the test of blood samples at IMMUNOBIOGRAM® will allow the prognosis of the expected response of the patient to the most common immunosuppressive drugs (tacrolimus, cyclosporine, azathioprine, mycophenolic acid, prednisone, sirolimus and everolimus).
The main objective of the clinical study is to confirm the potential clinical utility observed in the preliminary clinical study BH-PILOT whit the participation of 70 patients. This pilot study shown promising results of IMMUNOBIOGRAM® as an in vitro test to adjust immunosuppressive therapy in a personalized way in patients with kidney transplantation.
Preliminary results are expected to be available by 1Q2019