Frequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients

Phase 4

Completed

• Conditions: Inflammation; Anemia; Malnutrition
• Interventions: Drug: CERA

• Registration Number: NCT02232113
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief 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.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2014-08-03
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-04
• Last Update Submitted: 2014-09-04
• Study First Posted: 2014-09-05
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• HD patients with stable hematocrit (between 30~36%) under intravenous administration of CERA 100 μg once monthly for two months.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CERA	CERA	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.

Primary Outcome Measures

Name	Time	Method
Erythropoietic response	every 2 months for six months	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.

Secondary Outcome Measures

Name	Time	Method
Nutritional status and inflammatory markers	every 2 months for a total of 6 months	Nutritional status (albumin, prealbumin) and inflammatory markers \[interleukin 6, tumor necrosis factor-α (TNF-α)\]

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan