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Sacubitril valsartan sodium improves volume overload in peritoneal dialysis patients: a prospective randomized controlled clinical trial

Sacubitril valsartan sodium improves volume overload in peritoneal dialysis patients: a prospective randomized controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064883
Enrollment
Unknown
Registered
2022-10-20
Start date
2022-10-20
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

end stage kidney disease

Interventions

ARIN group:regular peritoneal dialysis combined with oral administration of ARIN
Control group:regular peritoneal dialysis

Sponsors

Shanghai Oriental Hospital (Affiliated Oriental Hospital of Tongji University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Voluntarily sign informed consent; 3. Regular peritoneal dialysis treatment for more than 3 months; 4. Initial assessment ECM/TBW>0.4, daily intake of sodium chloride 0.4 after 1 month.

Exclusion criteria

Exclusion criteria: 1. Allergy or inability to tolerate medication with Shakubactrivalsartan sodium: 2. History of symptomatic hypotension/systolic blood pressure 6.0mmol/L; 4. History of angioedema; 5. Abnormal liver function such as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)2-3 times the upper normal limit and total bilirubin over 2 times the upper normal limit; 6. Moderate to severe anemia (hemoglobin < 60g/L); 7. Patients with advanced malignant tumor, cirrhosis and severe liver insufficiency, new severe infection, active tuberculosis, history of acute myocardial infarction within 3 months before entering the study, history of major surgical trauma within 3 months, and occurrence of peritonitis within 3 months; 8. Have hepatitis B or HIV seropositive, or are receiving immunosuppressive drugs; 9. From hemodialysis and kidney transplantation to peritoneal dialysis; 10. Receive treatment with an automatic peritoneal dialysis machine; 11. Pregnant and lactating patients or those of childbearing age who cannot guarantee effective contraception; 12. Patients suffering from mental disorders and taking psychotropic drugs; 13. The doctor assessed that the patient was not easy to follow up or had poor compliance and was not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Bioimpedance body composition analysis;

Countries

China

Contacts

Public ContactLiu Na

Shanghai Oriental Hospital (Affiliated Oriental Hospital of Tongji University)

naliubrown@163.com+86 18918958730

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026