NCT02232113

Frequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Anemia
• Inflammation
• Malnutrition

Interventions

Type	Name	Description
DRUG	CERA	changing frequency of administration from once to twice monthly under a fixed total monthly dose of CERA

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2014-09-05
• Last updated: 2014-09-05

Locations

1 site across 1 country: Taiwan