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

Sponsor
The Affiliated Hospital of Qingdao University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05053893
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
11.3
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Roxadustat;Sacubitril Valsartan Sodium Tablets;
  • Drug: EPO; ACEI / ARB
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Parallel Controlled Trial of Roxadustat Combined withSacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome
Anticipated Study Start Date :
Sep 22, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    2. 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(%)

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Nephrology, Affiliated Hospital of Qingdao University Qingdao Shangdong China 266003

    Sponsors and Collaborators

    • The Affiliated Hospital of Qingdao University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guangqun Xing,MD, Chief physician; Professor, The Affiliated Hospital of Qingdao University
    ClinicalTrials.gov Identifier:
    NCT05053893
    Other Study ID Numbers:
    • XHASB-001
    First Posted:
    Sep 23, 2021
    Last Update Posted:
    Sep 23, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardio-Renal Syndrome
    Syndrome
    Valsartan
    Sacubitril and valsartan sodium hydrate drug combination

    Study Results

    No Results Posted as of Sep 23, 2021