Back to resultsSacubitril/Valsartan for CKD5 Stage Dialysis Patients
Primary Purpose
CKD5 Stage Dialysis, Heart Failure
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sacubitril/Valsartan
Irbesartan
Sponsored by
About this trial
This is an interventional treatment trial for CKD5 Stage Dialysis
Eligibility Criteria
Inclusion Criteria:
- CKD stage 5, starting regular hemodialysis or peritoneal dialysis for more than 1 month.
- NT-proBNP ≥2000pg/ml.
- 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.
Sites / Locations
- Department of Nephrology, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sacubitril/Valsartan
Irbesartan
Arm Description
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
the maximum tolerated dose of irbesartan was administered
Outcomes
Primary Outcome Measures
The effect of ARNI on blood pressure in patients with CKD who are on dialysis
The evaluation indicator include office blood pressure
Secondary Outcome Measures
The effect of ARNI on ambulatory blood pressure
The evaluation indicator include ambulatory blood pressure
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05243199
Brief Title
Sacubitril/Valsartan for CKD5 Stage Dialysis Patients
Official Title
Sacubitril/Valsartan for Dialysis Patients With CKD5 Stage Complicated With Hypertension- A Prospective, Randomized, Controlled Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CKD5 Stage Dialysis, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sacubitril/Valsartan
Arm Type
Experimental
Arm Description
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
Arm Title
Irbesartan
Arm Type
Active Comparator
Arm Description
the maximum tolerated dose of irbesartan was administered
Intervention Type
Drug
Intervention Name(s)
Sacubitril/Valsartan
Other Intervention Name(s)
ARNI
Intervention Description
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
Intervention Name(s)
Irbesartan
Other Intervention Name(s)
ARB
Intervention Description
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.
Primary Outcome Measure Information:
Title
The effect of ARNI on blood pressure in patients with CKD who are on dialysis
Description
The evaluation indicator include office blood pressure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The effect of ARNI on ambulatory blood pressure
Description
The evaluation indicator include ambulatory blood pressure
Time Frame
1 year
Title
The effect of ARNI on cardiac function in patients with CKD who are on dialysis
Description
The evaluation indicators include heart function-related indicators such as NT pro-BNP and EF value
Time Frame
1 year
Title
The safety of ARNI in patients with CKD who are on dialysis
Description
The evaluation indicators incidence of death (including death from cardiovascular events or other causes), hyperkalemia and other adverse events.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of Nephrology, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Sacubitril/Valsartan for CKD5 Stage Dialysis Patients
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