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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05053893

Enrollment

Registered

2021-09-23

Start date

2021-09-22

Completion date

2022-09-01

Last updated

2021-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardio-Renal Syndrome

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.

Interventions

DRUGRoxadustat;Sacubitril Valsartan Sodium Tablets;

Select the appropriate dose according to the patient's situation

DRUGEPO; ACEI / ARB

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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(%)
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.

Countries

China

Contacts

Primary ContactGuangqun Xing, Doctor

gqx99monash@163.com18661802178

Backup ContactTing Li, Master

lt20080607@126.com18661801532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026