Dapagliflozin Delays the Loss of Renal Function in Peritoneal Dialysis Patients
- Conditions
- Peritoneal Dialysis ComplicationRenal Function AggravatedSodium-glucose Co-transporter-2 Inhibitors
- Interventions
- Registration Number
- NCT06398977
- Lead Sponsor
- Sichuan Academy of Medical Sciences
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dagliflozin group Dapagliflozin 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.
- Primary Outcome Measures
Name Time Method Change in 24 urine volume Baseline, 2,12 and 24 weeks. The total amount of urine excreted over a 24-hour period. The patient's urine output was measured continuously for 2 days, and the average volume was calculated, with the unit being millilitres.
- Secondary Outcome Measures
Name Time Method Change in ultrafiltration Baseline, 2, 12 and 24 weeks. The total amount of water removed from the body through dialysis each day.
Change in blood pressure Baseline, 2, 12 and 24 weeks. The bloody pressure of the patient in the morning.
Change in urinary glucose concentration Baseline, 2, 12 and 24 weeks. The concentration of glucose in the 24-hour urine.
concentration of Dapagliflozin 3-O-Glucuronide in serum Baseline, 2, 12 and 24 weeks. Concentration of Dapagliflozin 3-O-Glucuronide in serum reflecting Dapagliflozin metabolism.
Change in HbA1C （Hemoglobin A1C) rate Baseline, 12 and 24 weeks. Rate of Glycated Hemoglobin (HbA1C) as an Indicator of Long-term Glycemic Control in Serum.
Change in urinary sodium concentration Baseline, 2, 12 and 24 weeks. The concentration of sodium in the 24-hour urine.
Change in body weight Baseline, 2, 12 and 24 weeks. The weight of the patient is measured on an empty stomach without containing dialysate.
Episodes of peritonitis 24 weeks. The number of episodes of a patient during the trial.
Hospitalization 24 weeks. The number of patients admitted to hospital during the trial.
Concentration in Dapagliflozin 3-O-Glucuronide in urine Baseline, 2, 12 and 24 weeks. Concentration of Dapagliflozin 3-O-Glucuronide in urine indicating Dapagliflozin metabolic activity.
Concentration in Dapagliflozin 3-O-Glucuronide in dialysate Baseline, 2, 12 and 24 weeks. Concentration of Dapagliflozin 3-O-Glucuronide in dialysate reflecting Dapagliflozin metabolism.
Change in renal Kt/Vurea Baseline, 2, 12 and 24 weeks. A measure used in peritoneal dialysis therapy to assess adequacy, representing the renal clearance of urea (K) over time (t) normalized to body water volume (V).
Change in BNP（Brain natriuretic peptide） Baseline, 2, 12 and 24 weeks. Concentration of serum BNP which could assess cardiac function.
Change in EF% Baseline and 24 weeks. The ejection fraction (EF%) value was measured using echocardiography by the hospital's ultrasound department, with all ultrasound examinations conducted by two attending physicians.
Change in serum sodium concentration Baseline, 2, 12 and 24 weeks. Concentration of sodium ions in the blood.
Change in dialysate sodium concentration Baseline, 2, 12 and 24 weeks. The concentration of sodium in the 24-hour dialysate.
Time of dropout PD 24 weeks. The point in time at which a patient either discontinues PD treatment or experiences death during the trail.
Trial Locations
- Locations (1)
Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospita
🇨🇳Chengdu, Sichuan, China