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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02232113

Enrollment

Registered

2014-09-05

Start date

2012-02-29

Completion date

2013-01-31

Last updated

2014-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Inflammation, Malnutrition

Keywords

malnutrition, inflammation, and anemia (MIA) syndrome,, hemodialysis,, erythropoietin stimulating agent (ESA),, cost-effectiveness,, pharmacokinetics,, endothelial dysfunction

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.

Interventions

DRUGCERA

changing frequency of administration from once to twice monthly under a fixed total monthly dose of CERA

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026