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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05691257
Other study ID # JRen
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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