Sacubitril/Valsartan for CKD5 Stage Dialysis Patients

Sacubitril/Valsartan for Dialysis Patients With CKD5 Stage Complicated With Hypertension- A Prospective, Randomized, Controlled Multicenter Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; CKD5 Stage Dialysis
• Intervention / Treatment: Drug: Sacubitril/Valsartan; Drug: Irbesartan

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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).; Other Names: ARNI
Active Comparator: Irbesartan; the maximum tolerated dose of irbesartan was administered	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.; Other Names: ARB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of ARNI on blood pressure in patients with CKD who are on dialysis	The evaluation indicator include office blood pressure	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of ARNI on ambulatory blood pressure	The evaluation indicator include ambulatory blood pressure	1 year
The effect of ARNI on cardiac function in patients with CKD who are on dialysis	The evaluation indicators include heart function-related indicators such as NT pro-BNP and EF value	1 year
The safety of ARNI in patients with CKD who are on dialysis	The evaluation indicators incidence of death (including death from cardiovascular events or other causes), hyperkalemia and other adverse events.	1 year

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 8, 2023

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Sacubitril and valsartan sodium hydrate drug combination; Irbesartan
• Other Study ID Numbers: (2020)(137)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No