Frequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients

Taipei Veterans General Hospital

Status and phase: Completed; Phase 4

Conditions: Anemia; Inflammation; Malnutrition

Treatments: Drug: CERA

Study type: Interventional

Funder types: Other

Identifiers

NCT02232113

2011-10-004IA

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

CERA

Experimental group

Description:

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.

Treatment:

Drug: CERA