NCT06398977

Dapagliflozin Delays the Loss of Renal Function in Peritoneal Dialysis Patients

Dapagliflozin Delays the Loss of Residual Renal Function in Patients Undergoing Peritoneal Dialysis: A Single-Center Randomized Open-Label Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Sichuan Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore the role of dagliflozin in preserving the residual renal function(RRF) in peritoneal dialysis (PD) patients.

Detailed description

Residual renal function (RRF) plays the role of removing water and body metabolic wastes, as well as secretion of erythropoietin and promotion of vitamin D absorption, which can maintain the stability of the internal environment. Several studies have demonstrated that preservation of RRF in PD patients reduces complications, increases dialysis adequacy and decreases mortality. In addition, residual renal function is an important factor in the technique survival. Methods to protect residual renal function in peritoneal dialysis patients include controlling blood pressure, controlling blood glucose, adjusting dialysis prescription, and using renin-angiotensin inhibitors. However, the above methods currently play only a limited role. Sodium-dependent glucose transporters 2 (SGLT2) inhibitors are drugs used in the treatment of type 2 diabetes mellitus that inhibit the reabsorption of glucose by the kidneys, causing glucose to be excreted in the urine and lowering blood glucose. Studies have demonstrated that SGLT2 inhibitors also attenuate renal tubular injury, reduce the excretion of proteinuria, and have a protective effect on RRF in non-dialysis patients with chronic kidney disease. However, there are no clinical studies demonstrating whether the use of SGLT2 inhibitors in peritoneal dialysis patients is renal protective. In light of this, this study introduces dagliflozin orally to PD patients over a 24-week period to explore its protective effects on RRF and cardiac health, with participants being randomly divided into a dagliflozin group and a control group. The results of this study will be beneficial in informing the clinical practice of SGLT2 inhibitors and improving dialysis outcomes in PD patients.

Conditions

• Peritoneal Dialysis Complication
• Renal Function Aggravated
• Sodium-glucose Co-transporter-2 Inhibitors

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Dapagliflozin10MG, PO once daily

Timeline

• Start date: 2024-03-11
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-05-03
• Last updated: 2024-05-03

Locations

1 site across 1 country: China