IMMUNOBIOGRAM® (IMBG) CLINICAL STUDIES IN KIDNEY TRANSPLANTATION
The most important challenge in Kidney Transplantation is to achieve the long-term survival of the transplanted organ, as 50% of patients will suffered a graft loss in the next 10 years following transplantation (unadjusted data).
To avoid the risk of graft rejection, patients require long term treatment with immunosuppressive drugs (IMS) but this treatment can also cause severe adverse events.
Currently IMS regimens are established empirically, based only on guidelines, monitoring of IMS plasmatic levels and side effects. The current strategy may lead to either under-immunosuppression (resulting in rejections) or over-immunosuppression (resulting in side effects).
The risk of graft rejection and the burden of adverse events are two of the most important challenges for the clinicians in the management of Kidney Transplant Patients. An adequate adjustment of immunosuppressive medications is needed to prevent them.
Currently there is no tool in clinical practice that allows to predict the individual immune response of each patient to the individual immunosuppressive drugs.

50% of patients in Kidney Transplantation
will suffer a graft loss in the next 10 years following transplantation
Immunobiogram ® is a first-in-class, blood-based in vitro diagnostic (IVD) bioassay, that can provide a pharmacodynamic readout of the immune response of individual patients to a battery of immunosuppressants commonly used in kidney transplantation and has the potential to help clinicians to individualize IMS treatment adjustment.
Immunobiogram ® has been tested for Kidney Transplantation (KT) in two clinical studies that belong to the TRANSBIO Project (Cellular BIOtechnology for prognosis and monitoring in renal TRANSplantation), supported by the European Union Horizon 2020 Programme for Research and Innovation as a SME instrument Phase 2 under grant agreement Nº 733248:
BH-PILOT 2015
BH-Pilot 2015 Study was a proof-of-concept clinical study performed in 2015-2016 in two important University Hospitals from Madrid. The study included 70 renal-transplanted patients at least 1 year after the transplant (immunosuppression maintenance period), and classified as high- immunological-risk, low-risk and standard based on their clinical and immunological characteristics.

TRANSBIO STUDY
TRANSBIO Study is an international, multicenter clinical study performed to confirm BH-Pilot 2015 study results and to achieve the technical validation of the IMBG. It was performed in nine major University Hospitals in Europe and USA with more than 200 patients recruited.
The study included 164 renal-transplanted patients at least 1 year after the transplant and the objectives were to evaluate IMBG robustness, the association of IMBG results with clinical prognoses and its consistency
The studies showed these results: