臨床研究等提出・公開システム

Date of registration	Jan. 27, 2026
Last modified on	Jan. 27, 2026
Trial ID	jRCT1032250682

Scientific Title	A Prospective Study on the Effects of H12-Hemodialyzer and Low-Albumin Leakage On-Line HDF on Nutritional Status
Public Title	A Prospective Study on the Effects of H12-Hemodialyzer and Low-Albumin Leakage On-Line HDF on Nutritional Status


Contact for Scientific Queries	Name	Hara Shoichiro
	Address	2-2-1 Kongo Yahatanishi-ku, Kitakyushu-shi, Fukuoka-ken
	Telephone	+81-93-618-3377
	E-mail	s.hara.imacli@gmail.com
Contact for Public Queries	Name	Hara Shoichiro
	Affiliation	Imamura Clinic, Medical Corporation
	Address	2-2-1 Kongo Yahatanishi-ku, Kitakyushu-shi, Fukuoka-ken
	Telephone	+81-93-618-3377
	E-mail	s.hara.imacli@gmail.com

Recruitment status	Pending

Anticipated date of first enrollment		Jan. 27, 2026
Target sample size		12
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	The study subjects were dialysis patients aged 65 or older who were outpatients or hospitalized at our hospital until January 31, 2027, and whose albumin levels were 3.5 g/dL or less in the results of regular blood tests at our hospital, and whose dialysis conditions were 4 hours and a blood flow rate of 200 ml/min.
	Exclusion Criteria	Patients who need to take ACE inhibitors as antihypertensive medication. Patients who are unable to make decisions.
	Age Minimum	65age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		chronic kidney disease
Intervention(s)		The dialyzer used for dialysis is changed every four months.
Primary Outcome(s)		Blood samples are taken for albumin, total cholesterol, and transthyretin before dialysis treatment. The amount of albumin and 40 amino acids removed from the dialysis waste fluid is measured. Nutritional assessment is performed using the nutritional risk index for Japanese hemodialysis patients, the nutritional risk index for the elderly, and the standardized protein catabolic rate.
Secondary Outcome(s)		Dry weight at blood test, weight gain between dialysis treatments, cardiothoracic ratio, and BMI are measured. Muscle strength is assessed by blood sampling using creatinine and %creatinine production rate before dialysis treatment. Urea nitrogen, creatinine, and beta2-microglobulin removal rates, as well as single pool-kt/v and clear space rate, are calculated, and dialysis efficiency is evaluated by the amount of urea nitrogen, creatinine, and beta2-microglobulin removed from the dialysis waste fluid. Anemia is assessed by hemoglobin, hematocrit, transferrin saturation, ferritin, and the amount of erythropoietin preparation used, as well as the use of iron preparations during the observation period. Dialysis fatigue is assessed using a visual analog scale for sleep and dietary status on dialysis treatment and non-dialysis treatment days. Inflammation status is assessed by C-reactive protein before dialysis treatment.

Name of Certified Review Board	Japanese Society for Technology of Blood purification
Address	Hyu-rikkukandabiru6kai 1-16-5 Kandasudacho Chiyoda-ku Tokyo-to, Tokyo
E-Mail	contact@jstb.jp
Approval Status	Approval
Date of approval	Dec. 25, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none