BH-Pilot 2015 in renal transplant was a clinical study performed in 2015-2016 in “La Paz” and “Puerta de Hierro” University Hospitals (Madrid) as a proof of concept study in patients with a renal transplantation. The study included 70 renal transplanted patients at least 1 year after the transplant (immunosuppression maintenance period).
The study outcomes indicated a positive proof of concept for IMBG that can be summarized in the following points:
1) Immunobiogram provided an individualized patient response pattern to immunosuppressive medication.
2) Sensitivity ranges could be determined in each patient for each of the drugs and doses tested.
3) Significantly associated low-sensitivity patterns to IS in IMBG have been observed in patients with high risk immunological-profile and who present worse clinical evolution.
4) Patients with a low-risk profile showed better sensitivity scores to IS in IMBG compared with other patients.
The classification of immunoassay profiles could be reproduced accurately by a neural network and thus completely automatized.
The outcomes of the study indicated that in renal transplantation IMBG enables to measure the sensitivity/resistance profile of patients to immunosuppressant medication, and it can detect patients with bad prognosis due to IS low sensitivity.