Sacubitril/Valsartan for CKD5 Stage Dialysis Patients

NCT ID: NCT05243199

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2023-03-08

Brief Summary

Hemodialysis or peritoneal dialysis CKD5 patients were randomly divided into Sacubitril/Valsartan and irbesartan treatment groups. Comparing the blood pressure, survival rates, the cardiac function, renal function,and adverse reactions of two groups, to evaluate whether the efficacy and safety of Sacubitril/Valsartan in the treatment of patients with CKD dialysis combined with heart failure is superior to that of irbesartan.

Conditions

CKD5 Stage Dialysis; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sacubitril/Valsartan

The initial dose of 50mg Qd was increased to 50mg Bid after 1 week and maintained to 100mg Bid after 2 weeks if the patient could tolerate it

Group Type: EXPERIMENTAL

Sacubitril/Valsartan

Intervention Type: DRUG

The initial dose of 50mg Qd was increased to 50mg Bid after 1 week and maintained to 100mg Bid after 2 weeks if the patient could tolerate it (no follow-up exit criteria were found).

Irbesartan

the maximum tolerated dose of irbesartan was administered

Group Type: ACTIVE_COMPARATOR

Irbesartan

Intervention Type: DRUG

The Initial dose of 75 mg Qd with sand, such as patients can tolerate and follow-up exit criteria (not appear, to 75 mg Bid to maintain after 1 week, 2 weeks can still be tolerance is raised to 150 mg Bid.

Interventions

Sacubitril/Valsartan

The initial dose of 50mg Qd was increased to 50mg Bid after 1 week and maintained to 100mg Bid after 2 weeks if the patient could tolerate it (no follow-up exit criteria were found).

Intervention Type: DRUG

Irbesartan

The Initial dose of 75 mg Qd with sand, such as patients can tolerate and follow-up exit criteria (not appear, to 75 mg Bid to maintain after 1 week, 2 weeks can still be tolerance is raised to 150 mg Bid.

Intervention Type: DRUG

Other Intervention Names

ARNI; ARB

Eligibility Criteria

Inclusion Criteria

• CKD stage 5, starting regular hemodialysis or peritoneal dialysis for more than 1 month.
• NT-proBNP ≥2000pg/ml.
• hypertension
• Voluntary informed consent.

Exclusion Criteria

• Unable to tolerate ACEI/ARB class antihypertensive drugs;
• History of symptomatic hypotension/systolic blood pressure <100mmHg at screening;
• Potassium >6.0mmol/L;
• History of angioedema;
• Abnormal liver function such as ALT and/or AST >=3 times normal upper limit (ULN), total bilirubin >= 2 times ULN;
• Moderate to severe anemia (hemoglobin <80g/L);
• Cardiac surgery/intervention/cardiac resynchronization therapy has been performed in the past 3 months or is planned in the next 12 months;
• Newly found malignant tumor (within 3 years), or undergoing radiotherapy/chemotherapy;
• Pregnant and lactating women, or those of childbearing age who are unable to guarantee effective contraception;
• New and serious life-threatening infections;
• Active infectious diseases such as active tuberculosis, active viral hepatitis and HIV infection;
• Persons suffering from mental disorders and taking psychotropic drugs;
• Patients with life expectancy less than 12 months;
• The doctor assessed that the patient was not easy to follow up or had poor compliance and was not suitable for enrollment;
• Patients who do not want to sign informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nan Chen,MD

Principal Investigator,Director,Foreign academicians of the French National Academy of Medical Sciences,Director of institute of Nephrology affiliated to Shanghai Jiao Tong University Medical College

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Nephrology, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

(2020)(137)

Identifier Type: -

Identifier Source: org_study_id