臨床研究等提出・公開システム

A multicenter, open-label, randomized, parallel-group comparative study on the efficacy of Intradialytic parenteral nutrition with ENEFLUID Injection in maintenance hemodialysis patients with malnutrition

IDPN-2 (IDPN-2)

40

The intervention group Age (average): 72.1 years old Sex: Male 12, Female 8 The control group Age (average): 72.1 years old Sex: Male 15, Female 4

Number of subjects enrolled in the clinical trial: 40 (20 intervention group, 20 control group) Number of subjects who discontinued before the study began:1 (control group) Number of subjects who discontinued during the study: 5 (4 study group, 1 control group)

The adverse events occurred 10 events in 7 patients among 20 patients in the intervention group and 12events in 5 patients among 19 patients in the control group. No adverse events were associated with the study or ENEFLUID infusions.

Primary endpoint: The change in serum TTR from the beginning of the study to 12 weeks later was not significantly different between the groups. Secondary endpoints: Energy and protein intakes tended to increase in the intervention group and decrease in the control group, with significant differences between the groups in the change from the beginning of the study to 12 weeks later. The change in plasma amino acid before and after dialysis were significantly less in the intervention group than in the control group. The frequency, duration, and AOC of hypoglycemia (<70mg/dL) during dialysis were significantly less in the intervention group than in the control group.

Malnourished maintenance hemodialysis patients received intradialytic parenteral nutrition by ENEFLUID infusion for 12 weeks. There were no differences in serum TTR between the groups. Dietary intake tended to increase in the intervention group and decrease in the control group. Compared to the control group, the intervention group had less decrease in post-dialysis plasma amino acid concentrations and more stable blood glucose during dialysis. There were no adverse events caused by ENEFLUID infusions.

June. 30, 2024

No

NA

https://jrct.mhlw.go.jp/latest-detail/jRCTs031220296

Kanno Yoshihiko

TOKYO MEDICAL UNIVERSITY HOSPITAL

6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo

kannoyh@tokyo-med.ac.jp

Kanno Yoshihiko

TOKYO MEDICAL UNIVERSITY HOSPITAL

6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo

+81-3-3342-6111

kannoyh@tokyo-med.ac.jp

Complete

Aug. 26, 2022

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

Malnourished maintenance hemodialysis patients with inadequate oral intake
(1)Patients aged 20 years or older at the time of informed consent
(2)Patients with a nutritional risk index for Japanese hemodialysis patients (NRI-JH) of 5 to 10 within 2 months prior to the start of the study
(3)Patients who can obtain informed consent from themselves (Patients who can obtain informed consent from themselves and their regal representatives if their capacity to give informed consent is found to decline)

(1)Patients who received maintenance hemodialysis for less than 6 months
(2)Patients who are contraindicated to receive ENEFLUID Injection
(3)Patients who received IDPN within 1 month
(4)Patients who are pregnant or wish to become pregnant
(5)Patients with type 1 diabetes
(6)Patients with severe infection
(7)Patients who have been diagnosed and treated for malignant tumors within the past 3 years (excluding basal cell carcinoma of the skin or carcinoma in the uterine cervix which was surgically resected)
(8)Patients who with amputation of the lower limbs
(9)Patients who deemed ineligible for the study

Both

Chronic kidney disease

Administration of ENEFLUID Injection (550mL) through the venous way of the dialysis circuit three times weekly during hemodialysis sessions over 12 weeks

Chronic kidney disease, dialysis, malnutrition

Intradialytic Parenteral Nutrition

serum transthyretin levels

(1) Clinical laboratory test values
(2) Nutritional indicators
(3) Daily dietary intake per kg of body weight (energy, protein)
(4) Body weight
(5) Concomitant drugs
(6) Amino acid concentration in the blood
(7) Glucose concentration in subcutaneous extracellular space

+81-3-5323-2027

July. 20, 2022

none