IDPN-2

JRCT ID: jRCTs031220296

Registered date:26/08/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic kidney disease
• Date of first enrollment: 26/08/2022
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Administration of ENEFLUID Injection (550mL) through the venous way of the dialysis circuit three times weekly during hemodialysis sessions over 12 weeks

Outcome(s)

• Primary Outcome: serum transthyretin levels

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Kanno Yoshihiko
• Secondary Sponsor: Otsuka Pharmaceutical Factory, Inc. Medical Affairs Department