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

Cardio-Renal Syndrome Clinical Trial

Official title:

A Randomized, Parallel Controlled Trial of Roxadustat Combined withSacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05053893
• Other study ID #: XHASB-001
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2021
• Source: The Affiliated Hospital of Qingdao University
• Contact: Guangqun Xing, Doctor
• Phone: 18661802178
• Email: gqx99monash[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardio-Renal Syndrome
• Syndrome

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Department of Nephrology, Affiliated Hospital of Qingdao University	Qingdao	Shangdong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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