IMBG has been initially tested in an observational, proof of concept study, which included patients with kidney transplant and with proven bad clinical evolution due to active rejection mechanisms, and patients with good clinical evolution.
We have two studies in place:
- BH Pilot 2015: published results show that there is a direct correlation between high risk patients (patients with active rejection mechanisms) and drug resistance in IMBG, as well as there is a correlation between low risk patients and drug sensitivity patterns.
- TRANSBIO study: it is an ongoing international study that will allow to test the correlation between drug resistance in IMBG and bad clinical evolution (defined as a progressive deterioration in renal function plus rejection signs in biopsy or an increase in DSA strength by Luminex). Also, it allows to test a correlation between drug sensitivity in IMBG and good clinical evolution (patients without rejection episodes, negative DSA, stable renal function and no changes in treatment). IMBG reproducibility will be also tested.
BH-PILOT STUDY 2015 and TRANSBIO STUDY will allow to ensure that IMBG is ready for implementation in the clinical laboratory and reproducible. TRANSBIO will allow to compare IMBG in kidney transplanted patients with good vs bad clinical evolution.
Additionally, 2 local studies are planned to be conducted during 2019/2020. The first one will allow to get prospective data about the clinical evolution of the patients included in BH-Pilot 2015 and to analyze the correlation between the sensitivity/resistance profile detected in IMBG and the patients´ clinical evolution 2 years later. The second one will compare the IMBG from the same patients when performed from a fresh or a frozen blood sample and between two different centers.