臨床研究等提出・公開システム

Date of registration	Feb. 23, 2022
Last modified on	Feb. 23, 2022
Trial ID	jRCT1040210152

Scientific Title	Evaluation of renal functional reserve using spot urine
Public Title	Simplified evaluatiion of renal functional reserve

Contact for Scientific Queries	Name	Isobe Shinsuke
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1 Handayama, Higashi-ku Hamamatsu, Japan
	Telephone	+81-53-435-2261
	E-mail	isobe58@hama-med.ac.jp
Contact for Public Queries	Name	Isobe Shinsuke
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1 Handayama, Higashi-ku Hamamatsu, Japan
	Telephone	+81-534352261
	E-mail	isobe58@hama-med.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Feb. 23, 2022
Target sample size		40
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy volunteer 1. 20-80 years old 2. Individuals without CKD 3. Individuals with written informed consent CKD patients 1. 20-80 years old 2. eGFR < 60ml/min/1.73m2, or evidence of proteinuria and/or hematuria 3. CKD patients with written informed consent
	Exclusion Criteria	Health volunteer 1. Those who compricated or are being treater other disease 2. Pregnant , lactating, or menstruating women 3. Those who are judged by the principal investigator or the investigator to be unsuitable for participation in the research CKD patients 1. Patients requiring hemodialysis or peritoneal dialysis 2. Sever acidosis 3. Congestive heart failure 4. Hyponatremia 5. Pregnant , lactating, or menstruating women 6. Treated with SGLT2 inhibitor, diuretics, or renin-angiotensin inhibitors. 7. Those who are judged by the principal investigator or the investigator to be unsuitable for participation in the research
	Age Minimum	20age old over
	Age Maximum	80age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		CKD patients
Intervention(s)		Creatinine clearance is measured amang infusion of 2h an amino acid solution (AMIZET B, TERUMO) at the 80ml/min to healthy volunteer or patients with chronick kidney disease.
Health Condition(s) Keyword		renal functional reserve
Primary Outcome(s)		We compare the correlation between the renal functional reserve which evaluated the conventional method and the simple method, for healthy volunteer and patients with chronic kidney disease.
Secondary Outcome(s)		Multiple linere regression analyses will be performed to evaluate the relationship the renal functional reserve using the simplified method and that evaluating the conventional method.

Primary Sponsor	Shinsuke Isobe, Internal Medicine 1, Hamamatsu University School of Medicine

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Ethics committee of Hamamatsu University School of Medicine
Address	1-20-1 Handayama, higashi-ku, Shizuoka, Japan, Shizuoka
Telephone	+81-53-435-2680
E-Mail	kenkyou.s@hama-med.ac.jp
Approval Status	Approval
Date of approval	Jan. 21, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none