Kidney Week

Abstract: FR-PO1060

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

Session Information

• Kidney Nutrition and Metabolism
  October 25, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Health Maintenance, Nutrition, and Metabolism

• 1500 Health Maintenance, Nutrition, and Metabolism

Authors

• Kabasawa, Hideyuki, Department of Clinical Nutrition Science, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Select State, Japan

Hideyuki Kabasawa, MD, PhD

• Hosojima, Michihiro, Department of Clinical Nutrition Science, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Select State, Japan

Michihiro Hosojima, MD, PhD

• Kanda, Eiichiro, Department of Health Data Science, Kawasaki Medical School, Okayama, Japan

Eiichiro Kanda, MD, PhD, MPH

• Nagai, Miho, Department of Nephrology, Tokyo Medical University, Tokyo, Japan

Miho Nagai, MD, PhD

• Murayama, Toshiko, Department of Health and Nutrition, Faculty of Human Life Studies, University of Niigata Prefecture, Niigata, Japan

Toshiko Murayama, RD

• Tani, Miyuki, Medical Affairs Department, Research and Development Center, Otsuka Pharmaceutical Factory, Inc., Tokyo, Japan

Miyuki Tani, MS

• Kamoshita, Satoru, Medical Affairs Department, Research and Development Center, Otsuka Pharmaceutical Factory, Inc., Tokyo, Japan

Satoru Kamoshita

• Kuroda, Akiyoshi, Research and Development Center, Otsuka Pharmaceutical Factory, Inc., Tokyo, Japan

Akiyoshi Kuroda, PhD

• Kanno, Yoshihiko, Department of Nephrology, Tokyo Medical University, Tokyo, Japan

Yoshihiko Kanno, MD, PhD

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.