Back to resultsObservation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure
Primary Purpose
CKD
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
LCZ 696
Sponsored by
About this trial
This is an interventional treatment trial for CKD focused on measuring Sacubitril/Valsartan, Advanced CKD Patients, Heart Failure
Eligibility Criteria
Inclusion Criteria:
- patients diagnosed with Chronic kidney disease (eGFR<60 ml/ min/1.73m²) and heart failure
- documented history of heart failure with associated signs or symptoms
- New York Heart Association (NYHA) classes II-IV
- mean sitting systolic blood pressure (msSBP) ⩾140mmHg
- good compliance
Exclusion Criteria:
- isolated right heart failure owing to pulmonary disease, dyspnoea from non-cardiac causes, primary valvular or myocardial diseases, or coronary or cerebrovascular diseases needing revascularization within 3months of screening or during the trial
- acute renal failure
- systolic blood pressure lower than 100 mm Hg at screening (<95 mm Hg at the randomisation visit)
- significant laboratory abnormalities at screening interfering with assessment of study drug safety or efficacy(such as serum potassium>5.5 or <3.5mmol/L, serum sodium<130mmol/L or alanine aminotransferase or aspartate aminotransferase>2 times the upper limit of the normal range)
- history of angioedema（drug-related or otherwise)
- any medications that have potential for drug-drug interaction with LCZ696 will not be allowed during the study 7)pregnant female
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LCZ696 treatment
Arm Description
LCZ696 200mg twice daily
Outcomes
Primary Outcome Measures
Change in estimated glomerular filtration rate(eGFR)
Blood samples will be collected for analysis of glomerular filtration rate(eGFR) every 2weeks .
Change in urinary microalbumin/creatinine ratio(uACR)
Urine samples will be collected for analysis of urinary microalbumin/creatinine ratio(uACR) every 2weeks.
Concentration of N terminal pro B type natriuretic peptide(NT-prpBNP)
Blood samples will be collected for analysis of concentration of N terminal pro B type natriuretic peptide(NT-proBNP) every 2weeks.
Secondary Outcome Measures
blood uric acid
Blood samples will be collected for analysis of uric acid every 2weeks.
Rate of HbA1c
Blood samples will be collected for analysis of HbA1c every 2weeks.
Systolic and diastolic blood pressure
Systolic and diastolic blood pressure will be measured every 2weeks.
left ventricle eject fraction
Cardiac ultrasound will be measured every 2weeks.
Concentration of postassium
Blood samples will be collected for analysis of concentration of postassium every 2weeks.
Concentration of serum troponin
Blood samples will be collected for analysis of concentration of serum troponin every 2weeks.
Concentration of alanine aminotransferase or aspartate aminotransferase
Blood samples will be collected for analysis of concentration of alanine aminotransferase or aspartate aminotransferase every 2weeks.
Concentration of sodio
Urine samples will be collected for analysis of concentration of sodion every 2weeks.
Full Information
NCT ID
NCT03771729
First Posted
November 30, 2018
Last Updated
December 9, 2018
Sponsor
The Second Affiliated Hospital of Harbin Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03771729
Brief Title
Observation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure
Official Title
Observation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 30, 2018 (Anticipated)
Primary Completion Date
May 28, 2019 (Anticipated)
Study Completion Date
June 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Affiliated Hospital of Harbin Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This paper will mainly present the renal results from a clinical study aimed to observe the effect of sacubitril/valsartan in advanced chronic kedney disease patients with heart failure.All patients will receive LCZ696.The results will be compared before and after treatment.
Detailed Description
On trial entry, patients will first receive LCZ696 50mg twice daily.According to the condition of disease and tolerance,the dose will be doubled every 2 weeks until the target maintenance dose 200mg twice daily is reached unless potassium or change in kidney function preclude a dose increase(reduction in dose will be permitted if the larger dose will not be tolerated, and temporary interruption will be permitted at any time if required for clinical reasons).The trial will be followed up for 12 weeks. Study visits will be scheduled at 2,4,6,8,10and12 weeks (and additional visits will be arranged where necessary to monitor participant safety).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CKD
Keywords
Sacubitril/Valsartan, Advanced CKD Patients, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LCZ696 treatment
Arm Type
Experimental
Arm Description
LCZ696 200mg twice daily
Intervention Type
Drug
Intervention Name(s)
LCZ 696
Other Intervention Name(s)
sacubitril/valsartan
Intervention Description
LCZ696 200mg twice daily
Primary Outcome Measure Information:
Title
Change in estimated glomerular filtration rate(eGFR)
Description
Blood samples will be collected for analysis of glomerular filtration rate(eGFR) every 2weeks .
Time Frame
12 weeks
Title
Change in urinary microalbumin/creatinine ratio(uACR)
Description
Urine samples will be collected for analysis of urinary microalbumin/creatinine ratio(uACR) every 2weeks.
Time Frame
12 weeks
Title
Concentration of N terminal pro B type natriuretic peptide(NT-prpBNP)
Description
Blood samples will be collected for analysis of concentration of N terminal pro B type natriuretic peptide(NT-proBNP) every 2weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
blood uric acid
Description
Blood samples will be collected for analysis of uric acid every 2weeks.
Time Frame
12 weeks
Title
Rate of HbA1c
Description
Blood samples will be collected for analysis of HbA1c every 2weeks.
Time Frame
12weeks
Title
Systolic and diastolic blood pressure
Description
Systolic and diastolic blood pressure will be measured every 2weeks.
Time Frame
12 weeks
Title
left ventricle eject fraction
Description
Cardiac ultrasound will be measured every 2weeks.
Time Frame
12 weeks
Title
Concentration of postassium
Description
Blood samples will be collected for analysis of concentration of postassium every 2weeks.
Time Frame
12 weeks
Title
Concentration of serum troponin
Description
Blood samples will be collected for analysis of concentration of serum troponin every 2weeks.
Time Frame
12 weeks
Title
Concentration of alanine aminotransferase or aspartate aminotransferase
Description
Blood samples will be collected for analysis of concentration of alanine aminotransferase or aspartate aminotransferase every 2weeks.
Time Frame
12 weeks
Title
Concentration of sodio
Description
Urine samples will be collected for analysis of concentration of sodion every 2weeks.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients diagnosed with Chronic kidney disease (eGFR<60 ml/ min/1.73m²) and heart failure
documented history of heart failure with associated signs or symptoms
New York Heart Association (NYHA) classes II-IV
mean sitting systolic blood pressure (msSBP) ⩾140mmHg
good compliance
Exclusion Criteria:
isolated right heart failure owing to pulmonary disease, dyspnoea from non-cardiac causes, primary valvular or myocardial diseases, or coronary or cerebrovascular diseases needing revascularization within 3months of screening or during the trial
acute renal failure
systolic blood pressure lower than 100 mm Hg at screening (<95 mm Hg at the randomisation visit)
significant laboratory abnormalities at screening interfering with assessment of study drug safety or efficacy(such as serum potassium>5.5 or <3.5mmol/L, serum sodium<130mmol/L or alanine aminotransferase or aspartate aminotransferase>2 times the upper limit of the normal range)
history of angioedema（drug-related or otherwise)
any medications that have potential for drug-drug interaction with LCZ696 will not be allowed during the study 7)pregnant female
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Clinical Study Report (CSR)
Learn more about this trial
Observation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure
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