SRS193 - A Phase I randomised clinical trial of cytokine adsorption therapy during kidney normothermic machine perfusion

Abstract Background Normothermic machine perfusion (NMP) facilitates ex-vivo graft assessment and treatment before transplantation. Kidneys with an enhanced inflammatory profile during NMP have significant graft dysfunction after transplantation. Incorporating a cytokine haemoadsoprtion filter (CytoSorb) into the NMP circuit markedly attenuates this inflammatory response. This has not been trialled in clinical practice. Methods We designed a single-centre phase I pilot study to assess the safety and feasibility of using CytoSorb during kidney NMP. Deceased donor kidneys were randomised 1:1 to receive 4 h of end-ischaemic NMP with (treated) or without (control) CytoSorb. Kidneys were then transplanted per standard practice. Results Nineteen of 20 participants were recruited between 15th January and 15th September 2025. Two kidneys were declined after NMP due to donor or recipient factors. Seventeen kidneys were ultimately transplanted. There were no significant adverse events. There were no significant between-group differences in donor and recipient demographics and total preservation time. At the end of NMP, the control group had higher mean renal blood flow at 250 ml/min/100 g (versus 160 ml/min/100g, P = 0.005) and lower intra-renal resistance at 0.14 mmHg/ml/min (versus 0.20 mmHg/ml/min, P = 0.007). Clinical outcomes were comparable between control and treated groups, with rates of primary graft function at 33 and 25% (P > 0.9), biopsy-proven acute rejection at 0% and 13% (P = 0.5), and 90-day mean eGFR at 43 ± 25 ml/min/1.73 m2 and 41 ± 32ml/min/1.73 m2 (P = 0.5) respectively. Discussion Preliminary results suggest that cytokine adsorption during kidney NMP is well-tolerated. We anticipate recruitment will be completed and efficacy data (cytokine and injury biomarker profile of perfusate samples) available by January 2026.