We have conducted two studies :
- BH Pilot 2015: it was demonstrated that in the IMMUNOBIOGRAM® there is a direct correlation between high risk patients (patients with active rejection mechanisms) and drug resistance, and low risk patients and drug sensitivity patterns.
- TRANSBIO International study: it is a study that has allowed to test the correlation between drug resistance in the IMMUNOBIOGRAM® and bad clinical evolution (progressive deterioration in renal function with a significant increase of creatinine and/or proteinuria plus rejection in biopsy, or an increase in strength of DSA expressed as Luminex MFI and with a titter of more than 3000UI). Also, it has allowed to test the correlation between drug sensitivity in the IMMUNOBIOGRAM® and good clinical evolution (patients without rejection episodes, negative DSA, stable renal function, and no changes in treatment). The IMMUNOBIOGRAM® consistency was also tested.
The IMMUNOBIOGRAM® has not been tested in a randomized clinical trial (RCT), but evaluated in an observational study which has included patients with proven bad clinical evolution due to active rejection mechanisms, and good clinical evolution in spite of very low immunosuppressant schemes.
An RCT in renal transplantation maintenance period (after >1 year post Tx) would have implied a large study with a long follow-up, while this kind of evidence is not needed for regulatory purposes to obtain marketing authorization.
BH-PILOT STUDY 2015 and TRANSBIO STUDY ensure that IMMUNOBIOGRAM® is ready for implementation in a clinical laboratory and reproducible.