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

Not Applicable

• Conditions: Cardio-Renal Syndrome
• Interventions: Drug: Roxadustat;Sacubitril Valsartan Sodium Tablets; Drug: EPO; ACEI / ARB

• Registration Number: NCT05053893
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-12
• Study First Submitted QC: 2021-09-13
• Last Update Submitted: 2021-09-13
• Study Start: 2021-09-22
• Study First Posted: 2021-09-23
• Last Update Posted: 2021-09-23
• Primary Completion: 2022-07-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New treatment group(Roxadustat combined with Sacubitril Valsartan Sodium Tablets)	Roxadustat;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.
Traditional treatment group(EPO combined with ACEI or ARB )	EPO; ACEI / 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.

Primary Outcome Measures

Name	Time	Method
Incidence of acute heart failure, acute myocardial infarction, severe hyperkalemia and severe anemia during treatment	Day0-Day90	Incidence rate = number of patients with the events/ total number of patients included in the study in this group.
Changes of hemoglobin level before and after treatment	Day0-Day90	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)
Changes of ejection fraction before and after treatment	Day0-Day90	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(%)

Trial Locations

Locations (1)

Department of Nephrology, Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shangdong, China