NCT05053893

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

September 22, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

September 12, 2021

Last Update Submit

September 13, 2021

Conditions

Cardio-Renal Syndrome

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

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

EXPERIMENTAL

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;

Traditional treatment group(EPO combined with ACEI or ARB )

EXPERIMENTAL

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

Interventions

Roxadustat;Sacubitril Valsartan Sodium Tablets;DRUG

Select the appropriate dose according to the patient's situation

Also known as: Entresto®
New treatment group(Roxadustat combined with Sacubitril Valsartan Sodium Tablets)
EPO; ACEI / ARBDRUG

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

Traditional treatment group(EPO combined with ACEI or ARB )

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology, Affiliated Hospital of Qingdao University

Qingdao, Shangdong, 266003, China

RECRUITING

MeSH Terms

Conditions

Cardio-Renal Syndrome

Interventions

sacubitril and valsartan sodium hydrate drug combinationAngiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHeart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Protease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Guangqun Xing, Doctor

CONTACT

18661802178gqx99monash@163.com

Ting Li, Master

CONTACT

18661801532lt20080607@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician; Professor

Study Record Dates

First Submitted

September 12, 2021

First Posted

September 23, 2021

Study Start

September 22, 2021

Primary Completion

July 1, 2022

Study Completion

September 1, 2022

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations

CN(1)