Dapagliflozin Delays the Loss of Renal Function in Peritoneal Dialysis Patients

Sichuan Academy of Medical Sciences

Status: Enrolling

Conditions: Peritoneal Dialysis Complication; Sodium-glucose Co-transporter-2 Inhibitors; Renal Function Aggravated

Treatments: Drug: Dapagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT06398977

DDLR-PD

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with PD duration between 1 month and 3 months.
• Patients aged between 18 and 75 years.
• Voluntary signing of informed consent.
• Stable use of a maximum tolerated dose of RAAS inhibitors for one month if hypertension is present.
• Daily urine output ≥ 400ml/day.
• Stable PD prescription for one month.

Exclusion criteria

• Pregnant and lactating women.
• Patients with type 1 diabetes mellitus.
• Patients with type 2 diabetes mellitus who have experienced diabetic ketoacidosis in the past.
• Patients with chronic liver disease, including non-alcoholic fatty liver disease, cirrhosis, ALT > 120 IU/L, and other clinically confirmed severe liver diseases.
• Patients with more than 2 episodes of urinary tract infection in the past six months.
• Patients with severe allergic reactions (rash or angioedema) to Dapagliflozin.
• Patients using the following medications: rifampicin, phenytoin.
• Patients with malignant tumors.
• Patients who developed peritonitis within one month.
• Patients undergoing combined hemodialysis treatment.
• Patients with a willingness for kidney transplantation within six months.
• Patients with a history of pancreatitis or pancreatic transplantation.
• Patients who experienced acute coronary syndrome or cerebrovascular events within one month.
• Hemoglobin level less than 90g/L.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Dagliflozin group

Active Comparator group

Description:

Patients in this group were treated with dagliflozin 10 mg, oral once daily, for 24 weeks, in addition to receiving basic treatments such as peritoneal dialysis and antihypertensive and hypoglycemic therapy.

Treatment:

Drug: Dapagliflozin

Control group

No Intervention group

Description:

This group of patients received peritoneal dialysis and basic treatments such as antihypertensive and hypoglycemic therapy.