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Clinical Trial Details

Trial ID: L0478
Source ID: NCT05691257
Associated Drug: Roxadustat
Title: Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Heart Failure|Chronic Kidney Diseases|Anemia
Interventions: DRUG: Roxadustat|DRUG: Recombinant human eythropoietin and/or Iron agents
Outcome Measures: 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|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|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|Change in Left Ventricular Diastolic Function, Change in E/e' is assessed by two-dimensional directed M-mode echocardiography, Up to 24 weeks|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|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|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|Change in Left atrial volume, Change in left atrial volume is assessed by two-dimensional directed M-mode echocardiography, Up to 24 weeks|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 | 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|Hyperkalemia, Hyperkalemia is defined as:Serum potassium \> 5.5 mmol/L, Up to 8 weeks|Thromboembolism, Thromboembolism is defined as:Deep vein thrombosis at follow-up, Up to 1 year
Sponsor/Collaborators: Sponsor: China-Japan Friendship Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 300
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-02-01
Completion Date: 2023-12-01
Results First Posted:
Last Update Posted: 2023-01-20
Locations:
URL: https://clinicaltrials.gov/show/NCT05691257