Trials / Unknown
UnknownNCT03771729
Observation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- The Second Affiliated Hospital of Harbin Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LCZ 696 | LCZ696 200mg twice daily |
Timeline
- Start date
- 2018-12-30
- Primary completion
- 2019-05-28
- Completion
- 2019-06-15
- First posted
- 2018-12-11
- Last updated
- 2018-12-11
Source: ClinicalTrials.gov record NCT03771729. Inclusion in this directory is not an endorsement.