Transplant Trial Watch

Efficacy of Integrated Risk Score Using Omics-Based Biomarkers for the Prediction of Acute Rejection in Kidney Transplantation: A Randomized Prospective Pilot Study.

Lim, J. H., et al.

International Journal of Molecular Sciences 2024; 25(10): 09

This study aimed to assess the efficacy of the integrated risk score of five different omics biomarkers for predicting the risk of acute rejection in kidney transplant patients with high immunologic risk.

Participants were randomly assigned to either the biomarker group and the control group. The biomarker group was informed about the integrated risk scores and adjustments to immunosuppression were made based on these scores, but this was not done in the control group.

40 de novo kidney transplant recipients with high immunologic risk.

The primary endpoint was 1-year estimated glomerular filtration rate (eGFR) posttransplantation. The secondary endpoints included the incidence of acute rejection, graft failure, frequency of graft biopsy and the comparision of tacrolimus trough levels.

1 year posttransplantation

CET Conclusions
This is a study in renal transplantation that investigates the utility of combined blood and urinary biomarkers in predicting acute rejection. The study group had a panel of 5 biomarkers monitored and available to clinicians to decide care progress and whether or not to conduct renal biopsy. The result was that the biomarker group had significantly fewer biopsies, but with the same one-year risk of acute rejection and graft function. Patients in the biomarker group were able to maintain a significantly lower tacrolimus trough level. The criticism of the study would be the small size and the short follow up, however the use of biomarkers in a clinical setting in this way is interesting and hopefully a key step on reducing reliance on transplant biopsies.

Jadad score

Data analysis
Per protocol analysis

Allocation concealment

Trial registration

Funding source
Non-industry funded