jDAPA-PD

JRCT ID: jRCT1031230624

Registered date:08/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Chronic heart failure, chronic kidney disease
• Date of first enrollment: 08/02/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): The dapagliflozin group will receive 10 mg dapagliflozin orally once daily for 24 weeks

Outcome(s)

• Primary Outcome: Change in extracellular water from baseline to week 24

Secondary Outcome

1) All-cause mortality events
2) First cardiovascular event (death due to cardiovascular disease, myocardial infarction, unstable angina, stroke and transient ischemic attack, pulmonary thromboembolism, and acute leg ischemia)
3) First event of hospitalization (excluding hospitalization for social reasons)
4) Duration of PD treatment
5) Change in body composition indices (body weight, BMI, ECW, ECW/height, ECW/total body water) from baseline to week 24
6) Change in systolic and diastolic blood pressure from baseline to week 24
7) Change in Kt/V urea from baseline to week 24
8) Change in BNP from baseline to week 24
9) Change in echocardiographic parameters (LVDd, LVDs, LVEF, LVMI, LAD, E/A) from baseline to week 24
10) Change in D/P cr and glucose concentration of dialysate at 4 hours by the frequently and short time peritoneal equilibration test (FAST PET)from baseline to week 24
11) Change in PD regimen (up, down, no change) from baseline to week 24
12) Weekly fluid removal (urine, PD, total) from baseline to week 24

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who provide written consent based on their own free will to participate in this study.
2) Patients who are 18 years of age or older
3) Patients who are undergoing peritoneal dialysis for the treatment of end-stage kidney disease for more than 3 months
4) Patients whose peritoneal dialysis regimen is stable for at least 4 weeks
5) Patients who are diagnosed with chronic heart failure and receiving standard treatment

Exclude criteria

1) Patients who are participating in other clinical studies
2) Patients who are pregnant or breast feeding
3) Patients who have received SGLT2 inhibitors within 4 weeks
4) Patients who have received hemodialysis within 4 weeks
5) Patients who are treated for peritonitis within 4 weeks
6) Patients with a daily urine volume of less than 500 mL
7) Patients who have difficulty with infusion and drainage of peritoneal dialysis dialysate
8) Patients who are considering discontinuation of peritoneal dialysis within 8 weeks after enrollment.
9) Patients who have difficulty performing bioelectrical impedance analysis tests (pacemakers, and limb defects)
10) Patients who are allergic to dapagliflozin
11) Patients who are considered inappropriate to participate by investigators

Related Information

• Primary Sponsor: Yamamoto Suguru