Efficacy and Safety of Intradialytic Parenteral Nutrition Using ENEFLUID in Malnourished Patients Receiving Maintenance Hemodialysis: A Multicenter, Randomized, Open-Label Study

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Background: The objective of this study was to investigate the efficacy and safety of intradialytic parenteral nutrition (IDPN) using ENEFLUID® (310 kcal, 550 mL) in mild-moderate malnutrition patients receiving maintenance hemodialysis. Methods: A total of 40 adult patients with a Nutritional Risk Index-Japanese Hemodialysis (NRI-JH) score of 5-10 were enrolled in this multicenter, randomized, open-label study. Patients in the intervention group received IDPN using ENEFLUID® via the dialysis circuit 3 times a week for 12 weeks; those in the control group did not. The primary endpoint was change in serum transthyretin (TTR). The secondary endpoints were changes in nutritional laboratory tests, nutritional parameters, food intake. Results: For both groups, mean age (72.1±11.4 years) and BMI (20.3±3.0), and median NRI-JH score [7.0 (interquartile range, 6 – 8)], did not differ. One patient withdrew before intervention, leaving 20 intervention and 19 control patients. Mean (95% confidence interval) change in serum TTR (mg/dL) at 12 weeks did not differ between groups: Intervention, 1.0 (-1.1 – 3.2); Control, -0.3 (-2.4 – 1.9); Intragroup difference, 1.3 (-1.7 – 4.3); P = 0.41. The values reflecting protein intake at 12 weeks compared to those on the study initiation day increased in the intervention group [the changes of blood urea nitrogen, 9.4 (2.6 – 16.2) mg/dL; P = 0.007, and normalized protein catabolic rate, 0.10 (0.02 – 0.18) g/kg/day; P = 0.02]. Mean food protein intake (g/kg/day) at 12 weeks increased in the intervention group and decreased in the control group, and differed between groups: Intervention, 0.12 (-0.03 – 0.28); Control, -0.18 (-0.43 – 0.08); Inter-group difference, 0.30 (0.00 – 0.60); P = 0.050. No adverse events occurred. Conclusion: In patients with mild to moderate malnutrition receiving ENEFLUID® for 12 weeks as IDPN, serum TTR was not improved, decreases in protein intake was mitigated, no adverse events occurred (Trial registration: jRCTs031220296). Funding: Commercial Support - Otsuka Pharmaceutical Factory, Inc.

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