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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05691257
• Other study ID #: JRen
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: China-Japan Friendship Hospital
• Contact: Mengxi Yang
• Phone: +8615120049452
• Email: mxtezuka[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a cohort study in patients with anemia with heart failure complicated with chronic kidney disease, evaluating the the efficacy and safety of roxadustat. Patients were divided into roxadustat group and control group according to whether roxadustat was used or not. 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 will be evaluated. The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography, heart failure characteristics, diabetes status, kidney function, cardiac function, natriuretic peptide, dialysis, and additional co-morbidities, concomitant medications, and others.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female, aged =18 years at the time of consent

2. Weight between 45-160kg

3. Definite diagnosis of heart failure: according to the diagnostic criteria for heart failure in "Chinese Heart Failure Diagnosis and Treatment Guidelines 2018"

4. eGFR <60mL/min/1.73 m^2 by CKD-EPI.

5. Diagnosed anemia: male hemoglobin <130 g/L, non-pregnant female hemoglobin <120 g/L.

6. Provision of signed informed consent prior to any study specific procedures.

Exclusion Criteria:

1. Acute or chronic active bleeding 6 months before enrollment.

2. Anemias due to thalassemia, sickle cell anemia, pure red aplastic anemia, hemolytic anemia, ect.

3. Thromboembolism requiring anticoagulation.

4. Severe Infection.

5. 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).

6. Severe malnutrition.

7. 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.

8. Patients who have received roxadustat treatment or are allergic to roxadustat.

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Diseases
• Heart Failure
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Roxadustat
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.
• Recombinant human eythropoietin and/or Iron agents
Other drugs to treat anemia include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Liver Injury	Liver injury is defined as: i) a rise of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to 3 times above the upper limit of normal [ULN], or ii) a rise of total bilirubin to 2 times above the upper limit of normal [ULN]	Up to 8 weeks
Other	Hyperkalemia	Hyperkalemia is defined as:Serum potassium > 5.5 mmol/L	Up to 8 weeks
Other	Thromboembolism	Thromboembolism is defined as:Deep vein thrombosis at follow-up	Up to 1 year
Primary	Change in the hemoglobin from baseline	Hemoglobin is calculated by the routine blood test	up to 8 week
Secondary	Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)	Change from baseline to week 12 in N-terminal pro-brain natriuretic peptide (NT-proBNP). Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication.	Up to 8 weeks
Secondary	Change in Left Ventricular Systolic Function	Change in left ventricular ejection fraction is assessed by two-dimensional directed M-mode echocardiography	Up to 24 weeks
Secondary	Change in Left Ventricular End-Diastolic Diameter	Change in left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography	Up to 24 weeks
Secondary	Change in Left Ventricular Diastolic Function	Change in E/e' is assessed by two-dimensional directed M-mode echocardiography	Up to 24 weeks
Secondary	Change in Low-density lipoprotein(LDL)	Change from baseline to week 8 in Low-density lipoprotein(LDL).Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication.	Up to 8 weeks
Secondary	Change in Serum ferritin	Change from baseline to week 8 in Serum ferritin.Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication.	Up to 8 weeks
Secondary	Change in Transferrin saturation	Change from baseline to week 8 in Transferrin saturation.Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication.	Up to 8 weeks
Secondary	Change in Left atrial volume	Change in left atrial volume is assessed by two-dimensional directed M-mode echocardiography	Up to 24 weeks
Secondary	Change in Left atrial volume index	Change in left atrial volume index is assessed by two-dimensional directed M-mode echocardiography	Up to 24 weeks