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A randomized and parallel controlled trial design of comparing the new treatment group of Roxadustat combined with Sacubitril Valsartan Sodium Tablets with the traditional treatment group of recombinant human erythropoietin (EPO) combined with ACEI or ARB in Chinese patients with cardiorenal anemia syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New treatment group(Roxadustat combined with Sacubitril Valsartan Sodium Tablets) | Experimental | 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. |
|
| Traditional treatment group(EPO combined with ACEI or ARB ) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roxadustat;Sacubitril Valsartan Sodium Tablets; | Drug | Select the appropriate dose according to the patient's situation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of hemoglobin level before and after treatment | By detecting blood routine,calculate the changes of hemoglobin.Change value of hemoglobin level(g/L) = baseline hemoglobin level(g/L) - hemoglobin level after treatment(g/L) | Day0-Day90 |
| Changes of ejection fraction before and after treatment | Cardiac ejection fraction was measured by cardiac ultrasound before and after treatment,and change of cardiac ejection fraction(%) = baseline cardiac ejection fraction level(%) - post-treatment cardiac ejection fraction level(%) | Day0-Day90 |
| Incidence of acute heart failure, acute myocardial infarction, severe hyperkalemia and severe anemia during treatment | Incidence rate = number of patients with the events/ total number of patients included in the study in this group. | Day0-Day90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guangqun Xing, Doctor | Contact | 18661802178 | gqx99monash@163.com | |
| Ting Li, Master | Contact | 18661801532 | lt20080607@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology, Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shangdong | 266003 | China |
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| ID | Term |
|---|---|
| D059347 | Cardio-Renal Syndrome |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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|
| EPO; ACEI / ARB | Drug | Select the appropriate ACEI /ARB according to the subject's situation or follow its previous medication |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020164 | Chemical Actions and Uses |