end stage renal disease
Conditions
Interventions
DAPA group:Dapagliflozin in combination with RASi
RASi group: RASi only
Sponsors
Shanghai East Hospital (East Hospital Affiliated to Tongji University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a) Age 18-75 years; b) Voluntary signing of informed consent; c) Regular peritoneal dialysis treatment with conventional glucose peritoneal dialysate for more than 3 months; d) Life expectancy greater than 1 year; e) Residual glomerular filtration rate (GFR) > 5ml/min/1.73m2 and urine output greater than 400ml/d. f) Use a stable dose of RASi for at least 1 month
Exclusion criteria
Exclusion criteria: a) dapagliflozin allergy or inability to tolerate medications: b) history of symptomatic hypotension/systolic blood pressure < 100 mmHg on screening; c) Chronic urinary tract infection or recurrent urinary tract infection in the past 6 months; d) Osteoporotic fracture within the past 6 months; e) Have gangrene with diabetic foot or other diabetes-related skin infections; f) Patients with a history of previous amputation, peripheral vascular disease, and neuropathy; g) abnormal liver function such as alanine aminotransferase (ALT) and/or glutaminase (AST) 2 to 3 times the upper limit of normal, and total bilirubin above 2 times the upper limit of normal; h) Patients with advanced malignant tumors, liver cirrhosis and severe liver insufficiency, new severe infection, active tuberculosis, history of acute myocardial infarction within three months before entering the study, history of major surgical trauma within three months, peritonitis within three months, etc.; i) Have active hepatitis B or HIV seropositive, or are receiving immunosuppressive medications; j) Conversion from hemodialysis and kidney transplantation to peritoneal dialysis; k) Receive an automated peritoneal dialysis machine and a new type of peritoneal dialysis treatment with icodextrin; l) Pregnant and lactating women, or those of childbearing age who cannot guarantee effective contraception; m) Those who suffer from mental disorders and take psychotropic drugs; n) the physician assesses that the patient is not easy to follow up or has poor adherence and is not suitable for enrollment; o) Patients who do not wish to sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse cardiovascular events; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood biochemical indexes;echocardiography; | — |
Countries
China
Contacts
Public ContactWang Yi
Shanghai Easthospital Hospital (East Hospital Affiliated to Tongji University)
Outcome results
None listed