P166 NURSING INVOLVEMENT IN AN EARLY PHASE STUDY ON THE EFFECTS OF A NOVEL TREATMENT FOR EPO-RESISTANT ANAEMIA IN HAEMODIALYSIS PATIENTS Leela Goldstein1, Jake Cinco1, Adam Rumjon1, Iain C Macdougall1 1 Renal Unit, King’s College Hospital, London BACKGROUND: Currently, the major treatments for the anaemia associated with chronic kidney disease are EPO therapy, intravenous iron, and blood transfusions. Several new therapies for treating anaemia are currently being investigated in clinical trials. One strategy that is being explored is to antagonise the effect of a substance called hepcidin, which is the key regulator of iron availability in the body. CKD patients, and particularly those on dialysis, have levels of hepcidin around four times as high as normal healthy individuals, and this is now believed to be part of the reason why some patients are resistant to EPO therapy. Recently, our unit was privileged to conduct the first study in the world of a new anti-hepcidin molecule called lexaptepid. Since this drug had never been given to any dialysis patients before, it was critical to ascertain that it was safe and well-tolerated in this patient population. STUDY PROTOCOL AND DESIGN: Under the supervision of the Principal Investigator, the research nurses conducted a single-blind placebo-controlled crossover study in 8 patients recruited from our main and satellite dialysis units.The patients attended a total of 8 visits: a screening visit and 7 other study visits on days 1, 8, 10, 12, 15, 22 and 36. All patients were administered a single IV injection of lexaptepid and a single IV injection ofa placebo one week apart. Blood samples were taken at 0h, 3h, 6h, 9h, 12h, 18h and 24h on days 1 and 8. Patients were required to stay overnight in our Clinical Trials Facility (CTF)staffed by our own team of renal research nurses, and they were also dialysed in the CTF by the dialysis-trained members of our research team. RESULTS:9 participants were recruited: 3 males and 6 females with a mean age of 58 + 10 years (1 participant dropped-out due to an unrelated adverse event and was replaced). 8 participants completed the study. The findings showed an increase in serum iron levels 3 hours post-dosing of lexaptepid that was not seen with placebo; peak levels were seen at 12 hours post-dose (Figure). There were no significant changes with the placebo treatment. There were no treatment-related adverse events or other safety concerns in this study. CONCLUSIONS:This is the first study ofan anti-hepcidin therapy in haemodialysis patients who have EPO-resistant anaemia. The initial findings are promising and merit further study. The main challenge from the research nursing point-of-view was covering the entire 24-hour period following the two intravenous injections, and being able to dialyse the patients in the Clinical Trials Facility. The research nurses continue to be involved in the next phase of development with this novel and exciting drug.