End-stage renal disease
Conditions
Interventions
Placebo group:Placebo
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Regular continuous ambulatory peritoneal dialysis (CAPD) =3 months; 2.Peritoneal dialysis solution using lactate as a buffer; 3.Residual urine volume >400ml or residual renal function (rGFR) =2ml/min/1.73m²; 4.Screening and randomization when serum potassium was <5.0 mmol/L; 5.Stable use of ACEI or ARB therapy for =3 months. 6.Age 18-75 years old; 7.Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients who regularly use icodextrin peritoneal dialysis solution; 2.Use lactate-G2.5% peritoneal dialysis solution >4L/d; 3.Patients undergoing hemodialysis concurrently; 4.Glycosylated hemoglobin>10%; 5.Symptomatic hypotension with an average systolic blood pressure of less than 90mmHg during screening or randomization; 6.Screening for acute ischemic cardiovascular and cerebrovascular events occurring within the past 30 days, such as ischemic stroke, transient ischemic attack, or acute coronary syndrome; 7.Patients with severe heart failure, including but not limited to NYHA class III-IV heart function, symptoms that cannot be controlled or improved by medication, and those with left ventricular assist devices; 8.Merge life-threatening or uncontrolled arrhythmias during screening and/or randomization, including but not limited to sustained ventricular tachycardia and atrial fibrillation, or resting ventricular rate 110 beats/min; 9.Within 30 days prior to enrollment, there was a severe active infection requiring systemic antibiotic treatment, including but not limited to peritoneal dialysis-associated peritonitis, peritoneal dialysis catheter-related infections, tuberculosis infection, etc.; 10.Screening for planned kidney transplantation within 6 months after the visit; 11.Known allergic reactions to the investigational drug (active ingredient or excipient); 12.Severe hepatic insufficiency (Child-Pugh Class C); 13.Patients who were screened within the previous 30 days and concurrently using eplerenone, spironolactone, any renin inhibitor, and unable to discontinue medication; 14.Concurrent use of potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers (discontinued at least 7 days prior to randomization); 15.Any other conditions or treatments that would make the subjects unsuitable for participation in this study, as well as any circumstances that would prevent the subjects from completing the entire planned study period (e.g., active malignant tumors or other diseases with an expected lifespan of less than 12 months); 16.Participation in or simultaneous enrollment in another interventional clinical study with administration of investigational medicinal product within 30 days prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in rGFR from baseline after 12 months of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| residual urine volume;Cardiovascular composite events;Residual renal function (cystatin C);Kt/V;Ccr;The impact on cardiac function (cardiac ultrasound parameters: left ventricular ejection fraction LVEF, left ventricular mass index LVMI); | — |
Countries
China
Contacts
Public ContactQiongqiong Yang
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed