Roxadustat Combined With Sacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome
NCT ID: NCT05053893
Last Updated: 2021-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-09-22
2022-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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New treatment group(Roxadustat combined with Sacubitril Valsartan Sodium Tablets)
Roxadustat(FibroGen, China), 100mg (45-60kg) or 120mg (≥ 60kg) each time, three times a week, orally on an empty stomach in the morning. The initial dose of Sacubitril Valsartan Sodium Tablets(Novartis, China) is 50mg, once a day, taken on an empty stomach in the morning, and gradually titrated from the minimum dose to the maximum tolerated dose.
Roxadustat;Sacubitril Valsartan Sodium Tablets;
Select the appropriate dose according to the patient's situation
Traditional treatment group(EPO combined with ACEI or ARB )
Recombinant human erythropoietin (SEBOR, 10000 units / Branch) was injected subcutaneously once a week; Perindopril tablets (Servier, China), taken on an empty stomach, gradually titrated from the minimum dose to the maximum tolerated dose.
EPO; ACEI / ARB
Select the appropriate ACEI /ARB according to the subject's situation or follow its previous medication
Interventions
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Roxadustat;Sacubitril Valsartan Sodium Tablets;
Select the appropriate dose according to the patient's situation
EPO; ACEI / ARB
Select the appropriate ACEI /ARB according to the subject's situation or follow its previous medication
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hemoglobin 60-110g / L (twice with an interval of at least 4 days);
* Volunteered to participate
Exclusion Criteria
* Malignant tumors
* Active liver disease
* Rheumatic immune diseases in active stage
* Hereditary or idiopathic angioedema
* Systolic blood pressure≥180 mmHg;diastolic blood pressure≥110 mmHg
* Acute myocardial infarction and unstable angina pectoris
* Severe parathyroidism
* Active peptic ulcer
* taking aliskiren
* Mental disease
* Alcohol and drug abuse
* Allergy to test drugs
18 Years
70 Years
ALL
No
Sponsors
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The Affiliated Hospital of Qingdao University
OTHER
Responsible Party
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Guangqun Xing,MD
Chief physician; Professor
Locations
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Department of Nephrology, Affiliated Hospital of Qingdao University
Qingdao, Shangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XHASB-001
Identifier Type: -
Identifier Source: org_study_id
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