Sacubitril/Valsartan for CKD5 Stage Dialysis Patients

March 14, 2023 updated by: Nan Chen,MD, Ruijin Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Nan Chen, Professor
  • Phone Number: 08602164370045
  • Email: cnrj100@126.com

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The effect of ARNI on blood pressure in patients with CKD who are on dialysis
Time Frame: 1 year
The evaluation indicator include office blood pressure
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The effect of ARNI on ambulatory blood pressure
Time Frame: 1 year
The evaluation indicator include ambulatory blood pressure
1 year
The effect of ARNI on cardiac function in patients with CKD who are on dialysis
Time Frame: 1 year
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
Time Frame: 1 year
The evaluation indicators incidence of death (including death from cardiovascular events or other causes), hyperkalemia and other adverse events.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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