Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia

NCT05691257 | Unknown Phase 4 DMC

• 1 other identifier: JRen
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to conduct a a cohort study to evaluate the efficacy and safety of the efficacy and safety of roxadustat for the treatment of anemia, quality of life and cardiac function in patients with heart failure and chronic kidney disease.

Conditions

Heart Failure; Chronic Kidney Diseases; Anemia

Keywords

Roxadustat; Anemia; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Change in the hemoglobin from baseline

  Hemoglobin is calculated by the routine blood test

  up to 8 week

Secondary Outcomes (9)

• Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

  Up to 8 weeks

• Change in Left Ventricular Systolic Function

  Up to 24 weeks

• Change in Left Ventricular End-Diastolic Diameter

  Up to 24 weeks

• Change in Left Ventricular Diastolic Function

  Up to 24 weeks

• Change in Low-density lipoprotein（LDL）

  Up to 8 weeks

Other Outcomes (3)

• Liver Injury

  Up to 8 weeks

• Hyperkalemia

  Up to 8 weeks

• Thromboembolism

  Up to 1 year

Study Arms (2)

Roxadustat group

EXPERIMENTAL

Roxadustat group: patients with heart failure and chronic kidney disease and anemia treated with roxadustat and other anemia correction drugs.

Drug: Roxadustat; Drug: Recombinant human eythropoietin and/or Iron agents

Control group

OTHER

Control group: patients with heart failure and chronic kidney disease and anemia who were treated with other drugs include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.)

Drug: Recombinant human eythropoietin and/or Iron agents

Interventions

Roxadustat DRUG

The initial dose of roxadustat was given according to body weight, which was more than 60kg: 100mg (three times a week); Weight less than 60kg: 70mg (three times a week); 2 weeks later, the corresponding indexes were rechecked and medication was adjusted according to hemoglobin. The target is hemoglobin 100-120g/L. Reference for medication Method: The use of roxadustat is the same as the RCT study of roxadustat in the treatment of anemia and the drug instructions of roxadustat published by N Engl J Med in 2019.

Roxadustat group

Recombinant human eythropoietin and/or Iron agents DRUG

Other drugs to treat anemia include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.)

Control group; Roxadustat group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥18 years at the time of consent
• Weight between 45-160kg
• Definite diagnosis of heart failure: according to the diagnostic criteria for heart failure in "Chinese Heart Failure Diagnosis and Treatment Guidelines 2018"
• eGFR \<60mL/min/1.73 m\^2 by CKD-EPI.
• Diagnosed anemia: male hemoglobin \<130 g/L, non-pregnant female hemoglobin \<120 g/L.
• Provision of signed informed consent prior to any study specific procedures.

You may not qualify if:

• Acute or chronic active bleeding 6 months before enrollment.
• Anemias due to thalassemia, sickle cell anemia, pure red aplastic anemia, hemolytic anemia, ect.
• Thromboembolism requiring anticoagulation.
• Severe Infection.
• Hepatic impairment aspartate transaminase \[AST\] or alanine transaminase \[ALT\] \>3x the upper limit of normal \[ULN\]; or total bilirubin \>2x ULN at time of enrolment).
• Severe malnutrition.
• Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding.
• Patients who have received roxadustat treatment or are allergic to roxadustat.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency, Chronic; Anemia

Interventions

roxadustat

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Mengxi Yang

CONTACT

+8615120049452; mxtezuka@163.com

Jiang Liu

CONTACT

+8619800361320

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 19, 2023
• Study Start: February 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01