Date: Sunday, June 12, 2016
Session Name: Poster Session B: Kidney: Cardiovascular and Metabolic
Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-7:00pm
Location: Halls C&D
Background: A major cause of morbidity and mortality in kidney transplant recipients are infections. In this post-hoc analysis of the POSTOP study we assessed all infections in the first year after kidney transplantation in patients treated with the Receptor Activator of Nuclear Factor kB Ligand (RANKL) inhibitor Denosumab compared with standard treatment to prevent bone loss after renal transplantation.
Methods: In this randomized, parallel-group, single center, academic trial we randomly assigned 90 kidney transplant recipients two weeks after surgery in a 1:1 ratio to receive denosumab (subcutaneous injections of 60 mg denosumab at baseline and after 6 months) or no treatment. We recorded and analyzed all infections which occurred during this one year trial.
Results: During the 12 month study period there were 349 adverse events (AE) in the denosumab group (7.6 per patient) and 273 in the control group (6.2 per patient), of which 146 (41.8%) and 99 (36.3%), respectively, were infection related (p = 0.16). There were no unexpected AE or SAE and no deaths. Episodes of urinary tract infection occurred more often in the denosumab than in the control group (51 vs 25), and a significantly higher proportion of patients were affected in the denosumab group than in the control group (24 vs 11, p=0.008). The number of infectious events was not significantly different with respect to transplant pyelonephritis and urosepsis (3 vs 5), CMV viremia (26 vs 24), polyoma (BK) viremia (12 vs 11), flu-like disease (17 vs 14) and herpes labialis infection (8 vs 3). In patients with urinary tract infection the spectrum of urine bacteria was similar in the denosumab and control group, but E. coli (17/51 vs 4/25 positive cultures) and Enterococcus faecalis (8/51 vs 1/25 positive cultures) occurred more frequently in the denosumab than in the control group.
Conclusions: Post-transplant treatment with denosumab to prevent bone loss is associated with more frequent episodes of urinary tract infection, whereas opportunistic infections occurred with similar frequency in both groups.
CITATION INFORMATION: Bonani M, Frey D, Brockmann J, Fehr T, Müller T, Graf N, Wüthrich R. Infections in De Novo Kidney Transplant Recipients Treated with the RANKL Inhibitor Denosumab: A Post-Hoc Analysis of the POSTOP Clinical Trial (NCT01377467). Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:Bonani M, Frey D, Brockmann J, Fehr T, Müller T, Graf N, Wüthrich R. Infections in De Novo Kidney Transplant Recipients Treated with the RANKL Inhibitor Denosumab: A Post-Hoc Analysis of the POSTOP Clinical Trial (NCT01377467). [abstract]. Am J Transplant. 2016; 16 (suppl 3). http://atcmeetingabstracts.com/abstract/infections-in-de-novo-kidney-transplant-recipients-treated-with-the-rankl-inhibitor-denosumab-a-post-hoc-analysis-of-the-postop-clinical-trial-nct01377467/. Accessed January 20, 2018.
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