CKDEarly Phase 1NCT03771729
Observation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure
A Early Phase 1 study testing LCZ 696 in people with CKD, run by The Second Affiliated Hospital of Harbin Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CKD
- What is being tested?
- LCZ 696
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2018to 15 Jun 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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).
- Conditions
- CKD
- Being tested
- LCZ 696
- Keywords
- Sacubitril/Valsartan, Advanced CKD Patients, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCZ 696Drug
Also called sacubitril/valsartan
LCZ696 200mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| LCZ696 treatment | Experimental | LCZ696 200mg twice daily Receives: Drug: LCZ 696 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in estimated glomerular filtration rate(eGFR)
Blood samples will be collected for analysis of glomerular filtration rate(eGFR) every 2weeks .
Measured: 12 weeks
Change in urinary microalbumin/creatinine ratio(uACR)
Urine samples will be collected for analysis of urinary microalbumin/creatinine ratio(uACR) every 2weeks.
Measured: 12 weeks
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.
Measured: 12 weeks
Secondary outcomes (8)
blood uric acid
Blood samples will be collected for analysis of uric acid every 2weeks.
Measured: 12 weeks
Rate of HbA1c
Blood samples will be collected for analysis of HbA1c every 2weeks.
Measured: 12weeks
Systolic and diastolic blood pressure
Systolic and diastolic blood pressure will be measured every 2weeks.
Measured: 12 weeks
left ventricle eject fraction
Cardiac ultrasound will be measured every 2weeks.
Measured: 12 weeks
Concentration of postassium
Blood samples will be collected for analysis of concentration of postassium every 2weeks.
Measured: 12 weeks
Concentration of serum troponin
Blood samples will be collected for analysis of concentration of serum troponin every 2weeks.
Measured: 12 weeks
Concentration of alanine aminotransferase or aspartate aminotransferase
Blood samples will be collected for analysis of concentration of alanine aminotransferase or aspartate aminotransferase every 2weeks.
Measured: 12 weeks
Concentration of sodio
Urine samples will be collected for analysis of concentration of sodion every 2weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start30 Dec 2018 (estimated)
- Primary completion28 May 2019 (estimated)
- Study completion15 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuanyi Du, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771729
- Sponsor's protocol ID
- 42411671-X
- Status last verified
- Dec 2018
- First submitted
- 30 Nov 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Clinical Study Report (CSR)
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT03771729
- Acronym / sponsor ID
- 42411671-X
- Conditions
- CKD
- Keywords
- Sacubitril/Valsartan, Advanced CKD Patients, Heart Failure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 30 Dec 2018 (estimated)
- Primary completion
- 28 May 2019 (estimated)
- Study completion
- 15 Jun 2019 (estimated)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCZ696 treatment | Experimental | Drug: LCZ 696LCZ696 200mg twice daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCZ 696Also: sacubitril/valsartanLCZ696 200mg twice daily | Drug | LCZ696 treatment |
Primary outcome
Change in estimated glomerular filtration rate(eGFR)
Time frame: 12 weeks
Blood samples will be collected for analysis of glomerular filtration rate(eGFR) every 2weeks .
Change in urinary microalbumin/creatinine ratio(uACR)
Time frame: 12 weeks
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)
Time frame: 12 weeks
Blood samples will be collected for analysis of concentration of N terminal pro B type natriuretic peptide(NT-proBNP) every 2weeks.
8 secondary outcomes
blood uric acid
Time frame: 12 weeks
Rate of HbA1c
Time frame: 12weeks
Systolic and diastolic blood pressure
Time frame: 12 weeks
left ventricle eject fraction
Time frame: 12 weeks
Concentration of postassium
Time frame: 12 weeks
Concentration of serum troponin
Time frame: 12 weeks
Concentration of alanine aminotransferase or aspartate aminotransferase
Time frame: 12 weeks
Concentration of sodio
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Individual participant dataSharing planned: Undecided. Clinical Study Report (CSR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LCZ 696 in people with CKD, run by The Second Affiliated Hospital of Harbin Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in estimated glomerular filtration rate(eGFR) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.