IDPN-2

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031220296

Enrollment

Registered

2022-08-26

Start date

2022-09-07

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease Chronic kidney disease, dialysis, malnutrition

Interventions

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

Intradialytic Parenteral Nutrition

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Secondary

Measure	Time frame
(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	—

Primary

Measure	Time frame
serum transthyretin levels	—

Contacts

Public ContactYoshihiko Kanno

TOKYO MEDICAL UNIVERSITY HOSPITAL

kannoyh@tokyo-med.ac.jp+81-3-3342-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 5, 2026