Roxadustat Combined With Sacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome

Qingdao University

Status: Unknown

Conditions: Cardio-Renal Syndrome

Treatments: Drug: Roxadustat;Sacubitril Valsartan Sodium Tablets;; Drug: EPO; ACEI / ARB

Study type: Interventional

Funder types: Other

Identifiers

NCT05053893

XHASB-001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed as regular dialysis patients with cardiorenal anemia syndrome
• Hemoglobin 60-110g / L (twice with an interval of at least 4 days);
• Volunteered to participate

Exclusion criteria

• Anemia caused by diseases other than CKD
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

New treatment group(Roxadustat combined with Sacubitril Valsartan Sodium Tablets)

Experimental group

Description:

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.

Treatment:

Drug: Roxadustat;Sacubitril Valsartan Sodium Tablets;

Traditional treatment group(EPO combined with ACEI or ARB )

Experimental group

Description:

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.

Treatment:

Drug: EPO; ACEI / ARB