An interventional study of Dapagliflozin in Peritoneal Dialysis Complication, Renal Function Aggravated and Sodium-glucose Co-transporter-2 Inhibitors, sponsored by Sichuan Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by Sichuan Academy of Medical Sciences · Not applicable, Interventional, and Treatment
This study aims to explore the role of dagliflozin in preserving the residual renal function(RRF) in peritoneal dialysis (PD) patients.
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.
Sichuan Academy of Medical Sciences is the lead sponsor of 18 studies on the registry; 11 are open to participants now.
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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.
Drug: Dapagliflozin
This group of patients received peritoneal dialysis and basic treatments such as antihypertensive and hypoglycemic therapy.
Dapagliflozin10MG, PO once daily
Also known as: dagliflozin
Change in 24 urine volume
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.
Time frame: Baseline, 2,12 and 24 weeks.
Change in renal Kt/Vurea
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).
Time frame: Baseline, 2, 12 and 24 weeks.
Change in BNP（Brain natriuretic peptide）
Concentration of serum BNP which could assess cardiac function.
Time frame: Baseline, 2, 12 and 24 weeks.
Change in EF%
The ejection fraction (EF%) value was measured using echocardiography by the hospital's ultrasound department, with all ultrasound examinations conducted by two attending physicians.
Time frame: Baseline and 24 weeks.
Change in ultrafiltration
The total amount of water removed from the body through dialysis each day.
Time frame: Baseline, 2, 12 and 24 weeks.
Change in HbA1C （Hemoglobin A1C) rate
Rate of Glycated Hemoglobin (HbA1C) as an Indicator of Long-term Glycemic Control in Serum.
Time frame: Baseline, 12 and 24 weeks.
Change in serum sodium concentration
Concentration of sodium ions in the blood.
Time frame: Baseline, 2, 12 and 24 weeks.
Change in urinary sodium concentration
The concentration of sodium in the 24-hour urine.
Time frame: Baseline, 2, 12 and 24 weeks.
Change in dialysate sodium concentration
The concentration of sodium in the 24-hour dialysate.
Time frame: Baseline, 2, 12 and 24 weeks.
Change in urinary glucose concentration
The concentration of glucose in the 24-hour urine.
Time frame: Baseline, 2, 12 and 24 weeks.
Change in blood pressure
The bloody pressure of the patient in the morning.
Time frame: Baseline, 2, 12 and 24 weeks.
Change in body weight
The weight of the patient is measured on an empty stomach without containing dialysate.
Time frame: Baseline, 2, 12 and 24 weeks.
Episodes of peritonitis
The number of episodes of a patient during the trial.
Time frame: 24 weeks.
Hospitalization
The number of patients admitted to hospital during the trial.
Time frame: 24 weeks.
Time of dropout PD
The point in time at which a patient either discontinues PD treatment or experiences death during the trail.
Time frame: 24 weeks.
Concentration in Dapagliflozin 3-O-Glucuronide in urine
Concentration of Dapagliflozin 3-O-Glucuronide in urine indicating Dapagliflozin metabolic activity.
Time frame: Baseline, 2, 12 and 24 weeks.
Concentration in Dapagliflozin 3-O-Glucuronide in dialysate
Concentration of Dapagliflozin 3-O-Glucuronide in dialysate reflecting Dapagliflozin metabolism.
Time frame: Baseline, 2, 12 and 24 weeks.
concentration of Dapagliflozin 3-O-Glucuronide in serum
Concentration of Dapagliflozin 3-O-Glucuronide in serum reflecting Dapagliflozin metabolism.
Time frame: Baseline, 2, 12 and 24 weeks.
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Studies of the drug tested here: Dapagliflozin
Sichuan Academy of Medical Sciences