Simplified evaluatiion of renal functional reserve

JRCT ID: jRCT1040210152

Registered date:23/02/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: CKD patients
• Date of first enrollment: 23/02/2022
• Target sample size: 40
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: 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: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Isobe Shinsuke