Roxadustat for Anemia in Patients With CKD

Study Overview
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Brief Summary
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A number of RCT studies have shown the safety and effectiveness of oral Roxadustat in the treatment of renal anemia, but there is a lack of evidence from cohort studies. A prospective cohort study is planed to conduct to evaluate the efficacy and safety of Roxadustat for renal anemia in the real world.

Detailed Description
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The prevalence of anemia in patients with chronic kidney disease (CKD) (15.4%) is twice that of the general population (7.6%), and the degree of anemia increases with the severity of CKD. A number of RCT studies have shown the safety and effectiveness of oral Roxadustat in the treatment of renal anemia, but there is a lack of evidence from cohort studies. A prospective cohort study is planed to conduct to evaluate the efficacy and safety of Roxadustat for renal anemia in the real world. It is planned to continuously recruit patients with renal anemia in Shenzhen Second People's Hospital from October 2020 to June 2023. The treatment of anemia will be recorded (Roxadustat or erythropoietin), and the observation period is one year. Collect the patient's demographic characteristics, drug dosage, adjustment plan, hemoglobin. The main outcome indicators were: the average change in Hb from baseline to 28-52 weeks, and the Hb response rate reached during two consecutive visits; the secondary outcome indicators were: the maintenance rate of the target Hb level, iron metabolism indicators, 0 to 8 weeks of Hb level increase rate, dose adjustment and safety indicators. The generalized additive mixed model of repeated measures was used to analyze the changes and differences of outcome indicators in different groups. Expected results: In the cohort study, the effectiveness and safety of roxastat in the treatment of renal anemia, the starting dose and the adjustment plan, provide a basis for guiding the clinical safe and effective application of roxastat.

Official Title
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A Prospective Cohort Study of Roxadustat for Anemia in Patients With Chronic Kidney Disease

Conditions
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Anemia of Chronic Kidney Disease

Intervention / Treatment
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* Drug: Roxadustat
* Drug: erythropoietin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the patient did not receive ESA treatment.The average Hb level of the last two (at least 7 days before the start of the study treatment and during the screening period) was <10 g/dL. Or patients who have received ESA: Patients with renal anemia who received ESA for at least 4 weeks within the approved dose range in China before the screening evaluation. The average Hb level of the last two (at least 7 days before the start of the study treatment and during the screening period) >=7 g/dL and <=12.0 g/dL; The expected survival time is more than 1 year; Exclusion Criteria: a history of severe, chronic, end-stage or uncontrolled autoimmune liver disease, Child Pugh score was grade C, or with active hepatitis; preparing for pregnancy or pregnancy or lactation; having anemia caused by any other disease other than CKD, such as thalassemia, sickle cell anemia, pure red aplastic anemia, hemolytic anemia, tumor-related anemia, chemotherapy-related anemia, and myelodysplastic syndrome; malignant tumor, such as prostate cancer, breast cancer, renal cell cancer or any other malignant tumor history or diagnosed .Any red blood cell infusion during the screening period; The patient is known to be allergic to the active substance (Roxadustat) or any excipient of the product;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Roxadustat<br>treatment with roxadustat | Drug: Roxadustat<br>* Oral<br>* Other names: Roxadustat capsules;|
| erythropoietin<br>treatment with erythropoietin | Drug: erythropoietin<br>* injection<br>* Other names: Recombinant Human Erythropoietin Injection(CHO cell);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean value of Hb levels over time | Hb will be measured throughout the period. | Up to Week 52 | 
| Achievement rate for target Hb level | Percent of participants who achieved target Hb level (≥10.0 ). | Up to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Hb levels at 4 weeks after using roxadustat | Hb levels at 4 weeks after using roxadustat | At Week 4 | 
| Mean Hb levels at 8 weeks after using roxadustat | Hb levels at 8 weeks after using roxadustat | At Week 8 | 
| the dose of Roxadustat used | the dose of Roxadustat used recorded monthly | Up to Week 52 | 
| Change from baseline in Hemoglobin (Hb) levels | Change from baseline in Hemoglobin (Hb) levels was recorded monthly | Up to Week 52 | 
| the proportion of patients with different Hb levels | the proportion of patients with different Hb levels | Up to Week 52 | 
| The proportion of patients with low response to ESA | The proportion of patients with low response to ESA | Up to Week 52 | 
| Concentration of Serum iron | Serum iron will be measured throughout the period. | Up to Week 52 | 
| Number of Participants with adverse events | adverse events will be record throughout the period. | Up to Week 52 |