Dapagliflozin Delays the Loss of Residual Renal Function in Patients Undergoing Peritoneal Dialysis: A Single-Center Randomized Open-Label Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in 24 urine volume
研究概览
简要总结
This study aims to explore the role of dagliflozin in preserving the residual renal function(RRF) in peritoneal dialysis (PD) patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Dagliflozin group
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.
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Change in 24 urine volume
时间窗: 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.
次要结局
- Change in ultrafiltration(Baseline, 2, 12 and 24 weeks.)
- Change in blood pressure(Baseline, 2, 12 and 24 weeks.)
- Change in urinary glucose concentration(Baseline, 2, 12 and 24 weeks.)
- concentration of Dapagliflozin 3-O-Glucuronide in serum(Baseline, 2, 12 and 24 weeks.)
- Change in HbA1C （Hemoglobin A1C) rate(Baseline, 12 and 24 weeks.)
- Change in urinary sodium concentration(Baseline, 2, 12 and 24 weeks.)
- Change in body weight(Baseline, 2, 12 and 24 weeks.)
- Episodes of peritonitis(24 weeks.)
- Hospitalization(24 weeks.)
- Concentration in Dapagliflozin 3-O-Glucuronide in urine(Baseline, 2, 12 and 24 weeks.)
- Concentration in Dapagliflozin 3-O-Glucuronide in dialysate(Baseline, 2, 12 and 24 weeks.)
- Change in renal Kt/Vurea(Baseline, 2, 12 and 24 weeks.)
- Change in BNP（Brain natriuretic peptide）(Baseline, 2, 12 and 24 weeks.)
- Change in EF%(Baseline and 24 weeks.)
- Change in serum sodium concentration(Baseline, 2, 12 and 24 weeks.)
- Change in dialysate sodium concentration(Baseline, 2, 12 and 24 weeks.)
- Time of dropout PD(24 weeks.)
研究者
Jin Chen
vice professor
Sichuan Academy of Medical Sciences