End-stage renal disease
Conditions
Interventions
Sacubitril-Valsartan group:Standard treatment of peritoneal dialysis+ oral taken Sacubitril-Valsartan
control group:Standard treatment of peritoneal dialysis
Sponsors
The third xiangya hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-75 years old,male and female; 2. The patients were treated with maintenance peritoneal dialysis for more than 3 months, and their 24-hour urine volume>=200ml; 3. Patients agree to be enrolled voluntarily in this study,and ICF was signed.
Exclusion criteria
Exclusion criteria: 1. Peritoneal dialysis related peritonitis occurred within 4 weeks before screening; 2. Myocardial infarction, unstable angina pectoris, cardiovascular revascularization surgery (such as stent or bypass surgery) or cerebrovascular accident occurred within 12 weeks before screening, or planned to undergo cardiovascular revascularization surgery during the trial period; 3. Subjects who have previously received kidney transplantation and are currently receiving immunosuppressive therapy; 4. Severe liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding the upper limit of normal (ULN) by 2.0 times, or total bilirubin more than 1.5 ULN; 5. Alcohol or drug abuse, cachexia and mental disorders; 6. Known to be allergic or intolerant to Sacubitril-Valsartan; 7. Patients who used ACEI / ARB or Sacubitril-Valsartan within 4 weeks before screening; 8. Patients with long-term use of diuretics; 9. Patients who have family planning, unable to contraception, or breast-feeding; 10. Patients are participating in other clinical trials or have participated in in other clinical trials 4 weeks before screening; 11. The patients whom investigators did not consider appropriate to participate the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease of residual renal function and residual urine in 24 weeks;Heart color Doppler ultrasound; | — |
Secondary
| Measure | Time frame |
|---|---|
| Variation value of LVEF from baseline to week 24;Decrease of residual renal function and residual urine in 4 weeks and 12 weeks;Effects of nutrition index, quality of life and psychological status after 24 weeks of treatment; | — |
Countries
China
Contacts
Public ContactHao Zhang/Bin Yi
The Third Xiangya Hospital of Central South University
Outcome results
None listed