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

Primary Purpose

Cardio-Renal Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Roxadustat;Sacubitril Valsartan Sodium Tablets;

EPO; ACEI / ARB

About this trial

This is an interventional treatment trial for Cardio-Renal Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Nephrology, Affiliated Hospital of Qingdao UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

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

Traditional treatment group(EPO combined with ACEI or ARB )

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)

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(%)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05053893

First Posted

September 12, 2021

Last Updated

September 13, 2021

Sponsor

The Affiliated Hospital of Qingdao University

1. Study Identification

Unique Protocol Identification Number

NCT05053893

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 22, 2021 (Anticipated)

Primary Completion Date

July 1, 2022 (Anticipated)

Study Completion Date

September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Affiliated Hospital of Qingdao University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardio-Renal Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

Traditional treatment group(EPO combined with ACEI or ARB )

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Roxadustat;Sacubitril Valsartan Sodium Tablets;

Other Intervention Name(s)

Entresto®

Intervention Description

Select the appropriate dose according to the patient's situation

Intervention Type

Drug

Intervention Name(s)

EPO; ACEI / ARB

Intervention Description

Select the appropriate ACEI /ARB according to the subject's situation or follow its previous medication

Primary Outcome Measure Information:

Title

Changes of hemoglobin level before and after treatment

Description

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)

Time Frame

Day0-Day90

Title

Changes of ejection fraction before and after treatment

Description

Time Frame

Day0-Day90

Title

Incidence of acute heart failure, acute myocardial infarction, severe hyperkalemia and severe anemia during treatment

Description

Incidence rate = number of patients with the events/ total number of patients included in the study in this group.

Time Frame

Day0-Day90

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guangqun Xing, Doctor

Phone

18661802178

gqx99monash@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ting Li, Master

Phone

18661801532

lt20080607@126.com

Facility Information:

Facility Name

Department of Nephrology, Affiliated Hospital of Qingdao University

City

Qingdao

State/Province

Shangdong

ZIP/Postal Code

266003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gungqun Xing, Doctor

Phone

186661802178

gqx99monash@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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