The effects of empagliflozin on ultrafiltration in patients with peritoneal dialysis

JRCT ID: jRCTs051230081

Registered date:01/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with chronic heart failure on peritoneal dialysis (PD)
• Date of first enrollment: 05/12/2023
• Target sample size: 36
• Study type: Interventional

Intervention(s)

1. Empagliflozin-Placebo group
The patients receive empagliflozin 10 mg orally once daily for 8 weeks, followed by a 4-week washout period, and then receive placebo once daily for 8 weeks.
2. Placebo-Empagliflozin group
The patients receive a placebo orally once daily for 8 weeks, followed by a 4-week washout period, and then receive empagliflozin 10mg once daily for 8 weeks.

Outcome(s)

• Primary Outcome: Change in ultrafiltration volume with dextrose peritoneal dialysis solution after 8 weeks of the treatment period (ultrafiltration volume is the average of 5 days excluding the maximum and minimum days out of 7 consecutive days)

Secondary Outcome

(1) Changes in NT-proBNP and BNP
(2) Changes in FAST PET-related factors: ultrafiltration volume, sodium, potassium, glucose, urea nitrogen, creatinine, uric acid,protein,IL-6, CA-125, dialysate to serum creatinine ratio
(3) Changes in 24-hour urine-related factors: urine volume, sodium, potassium, glucose, urea nitrogen, creatinine, uric acid, urine protein,urea clearance, creatinine clearance (mean of urea and creatinine clearance)
(4) urinary kidney injury molecule-1
(5) Changes in anemia-related factors: hemoglobin, hematocrit, ferritin, transferrin saturation
(6) Changes in body weight and blood pressure
(7) Changes in body composition: intracellular fluid volume, extracellular fluid volume, fluid overload
(8) Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

(1) Age >=18 and <=90 years
(2) BNP >= 40pg/mL, NT-proBNP >= 400 pg/mL, structural heart disease (left atrial enlargement and/or left ventricular hypertrophy), elevated filling pressures, or a history of hospitalization for heart failure
(3) Standard medical therapy for heart failure (at least one of the following: loop diuretics, ACEIs, ARBs, ARNIs, beta-blockers, MRAs)
(4) PD vintage >= 3 months
(5) Patients using more than 3 liters of dextrose peritoneal dialysis solution per day
(6) Patients who voluntarily provide consent for participation in this study

Exclude criteria

(1) Treatment with SGLT2 inhibitors within 3 months prior to enrollment
(2) Patients who are not expected to survive more than 1 year after enrollment
(3) On a hybrid therapy of peritoneal dialysis and hemodialysis
(4) Current peritonitis or a history of peritonitis within the past 2 months
(5) Pregnant or breast-feeding
(6) Active infections
(7) Current participation in clinical trials with intervention
(8) Patients who are judged by the Investigator to be inappropriate for the study for reasons not specified elsewhere

Related Information

• Primary Sponsor: Doi Yohei
• Source(s) of Monetary Support: Nippon Boehringer Ingelheim Co., Ltd.