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

September 13, 2021 updated by: Guangqun Xing,MD, The Affiliated Hospital of Qingdao University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shangdong
      • Qingdao, Shangdong, China, 266003
        • Recruiting
        • Department of Nephrology, Affiliated Hospital of Qingdao University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Roxadustat;Sacubitril Valsartan Sodium Tablets;
Select the appropriate dose according to the patient's situation
Other Names:
  • Entresto®
Experimental: 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.
Drug: EPO; ACEI / ARB
Select the appropriate ACEI /ARB according to the subject's situation or follow its previous medication

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Qingdao University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 22, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

September 12, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 23, 2021

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHASB-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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