Randomized controlled trial to evaluate the efficacy of Sodium glucose transporter 2 inhibitor in peritonealdialysis patients

JRCT ID: jRCT1011210022

Registered date:16/07/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Kidney Disease
• Date of first enrollment: 04/08/2021
• Target sample size: 36
• Study type: Interventional

Intervention(s)

After consent and registering patients,registration will be assigned by the next visit (week0) or on the day of the visit at week 0. Blood test is performed on the visit day (week 0), and the group is divided into a group that started taking canagliflozin 100 mg according to the allocation and a group that started taking
canagliflozin from the 24thweek of observation . Oral administration is continued for 52 weeks.

Outcome(s)

• Primary Outcome: BNP

Secondary Outcome

1)The following rate of change between 0 week and each point of time in the prior group and control
group
1. glycemic control and HbA1c
2. treatment of peritoneal dyalisis (peritoneal dialysis fluid , KT/Vurea , water removal, amount of ESA
)
3. cardiac ultrasound and cardiothoracic ratio
4. holter ECG ,Carotid Ultrasound, and CT
5. CVD biomarker
6. oxidative stress marker
7. bone metabolism markers
8. bone mineral density
9. blood pressure, body weight, BMI
2)BNP at other time points and BNP change amount at each point
3) The following rate of change comparing the time points of each test before and after administration of canagliflozin
1. glycemic control and HbA1c
2. treatment of peritoneal dyalisis (peritoneal dialysis fluid , KT/Vurea , water removal, amount of ESA)
3. cardiac ultrasound and cardiothoracic ratio
4. holter ECG ,Carotid Ultrasound, and CT
5. CVD biomarker
6. oxidative stress marker
7. bone metabolism markers
8. bone mineral density
9. blood pressure, body weight, BMI
10. BNP

Key inclusion & exclusion criteria

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

Include criteria

Patients who is over 20 years old
Patients diagnosed with type 2 diabetes
Patients from whom written informed consent was
obtained

Exclude criteria

Patients who undergo PD less than 3 months
Patients with unstable blood pressure
Patients deemed inadequate for monitoring
during study period, as determined by investigator
s.

Related Information

• Primary Sponsor: Nishio Saori