BACKGROUND: Infections are a major cause of morbidity and mortality in kidney allograft recipients. In this posthoc analysis of a randomized clinical trial which tested the effect of denosumab on bone mineral density we assessed the impact of this drug on the incidence and severity of infections in the first year after kidney transplantation.
METHODS: In this clinical trial we randomized 90 de novo kidney transplant recipients shortly after transplantation to either denosumab on top of standard treatment (calcium and vitamin D) (n=46), or to standard treatment alone (n=44). Among all adverse events we analyzed all infections that occurred within the first year after transplantation, and compared their incidence and severity in both groups.
RESULTS: Overall we identified more infections (n=146) in the denosumab group than in the control group (n=99). The most common infections were urinary tract infection (cystitis) (34.9% vs 25.2%), CMV viremia (17.8% vs 24.2%), flu-like syndrome (11.6% vs 14.1%), polyoma (BK) viremia (8.2% vs 11.1%), and herpes simplex infections (5.5% vs 4.0%). Episodes of urinary tract infection (cystitis) occurred more often in the denosumab than in the control group (51 vs 25 episodes in 24 vs 11 patients, p=0.008), whereas episodes of transplant pyelonephritis or urosepsis were not more frequent (3 vs 5 episodes).
CONCLUSIONS: This post-hoc analysis reveals that treatment with denosumab to prevent bone loss in first-year kidney transplant recipients was associated with more frequent episodes of urinary tract infections, whereas other infections occurred with similar frequency in both treatment groups.