Frequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients

Study Overview
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Brief Summary
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The response of Continuous Erythropoietic Receptor Activator (CERA) with different dose interval and the survey for influence factors: We aim to evaluate a better clinical response which can be achieved by different dosing interval of a fixed dose of CERA. We expect this study can determine the dosing schedule with better clinical response to CERA and identify the associated factors predicting the cost-effectiveness of CERA in maintenance hemodialysis (HD) patients in Taiwan.

Detailed Description
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We included HD patients with stable hematocrit (between 30 36%) under intravenous administration of CERA 100 μg once monthly for two months. Then they were shifted to receive CERA 50μg twice monthly for anther two months and finally they were shifted back to receive CERA 100 μg once monthly again for additional two months. Then we measured and compared the erythropoietic response (hematocrit, hemoglobin), profiles of iron status as well as nutritional status and inflammatory markers among the study subjects every two months for a total of 6 months. Those who had bleeding or received surgery or blood transfusion were excluded.

Official Title
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The Response of Continuous Erythropoietic Receptor Activator (CERA) With Different Dose Interval and the Survey for Influence Factors

Conditions
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Anemia, Inflammation, Malnutrition

Intervention / Treatment
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* Drug: CERA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HD patients with stable hematocrit (between 30 36%) under intravenous administration of CERA 100 μg once monthly for two months. Exclusion Criteria: HD patients were excluded due to active bleeding (major trauma, gastric ulcer bleeding, or surgery), blood transfusion or administration of additional erythropoietic stimulating agent (ESA) other than CERA within the follow-up period during the study perod of 6 months. People who discontinued CERA as their ESA were also excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CERA<br>We included HD patients with stable hematocrit (between 30 36%) under intravenous administration of CERA 100 μg once monthly for two months. Then they were shifted to receive CERA 50μg twice monthly for anther two months and finally they were shifted back to receive CERA 100 μg once monthly again for additional two months. Then we compared the hematocrit, nutrition status and inflammation markers every two months for 6 months totally. Those who had bleeding or received surgery or blood transfusion were excluded. | Drug: CERA<br>* changing frequency of administration from once to twice monthly under a fixed total monthly dose of CERA<br>* Other names: Brand name：Mircera®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythropoietic response | We measured and compared the hematocrit, hemoglobin, and iron status profiles (ferritin, iron, total iron binding capacity) among those enrolled patients every 2 months for 6 months totally. | every 2 months for six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status and inflammatory markers | Nutritional status (albumin, prealbumin) and inflammatory markers [interleukin 6, tumor necrosis factor-α (TNF-α)] | every 2 months for a total of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malnutrition, inflammation, and anemia (MIA) syndrome,, hemodialysis,, erythropoietin stimulating agent (ESA),, cost-effectiveness,, pharmacokinetics,, endothelial dysfunction