Clinical trial NCT02232113: Frequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients
Official title: The Response of Continuous Erythropoietic Receptor Activator (CERA) With Different Dose Interval and the Survey for Influence Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Inflammation
Malnutrition
Keywords: malnutrition, inflammation, and anemia (MIA) syndrome,
hemodialysis,
erythropoietin stimulating agent (ESA),
cost-effectiveness,
pharmacokinetics,
endothelial dysfunction
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Taipei City Hospital
First posted: 2014-09-05
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Erythropoietic response
timeFrame: every 2 months for six months
Secondary outcomes:
measure: Nutritional status and inflammatory markers
timeFrame: every 2 months for a total of 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Division of Nephrology and Department of Medicine, Taipei Veterans General Hospital
name: Chih-Ching Lin, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Liu WS, Wu YL, Li SY, Yang WC, Chen TW, Lin CC. The waveform fluctuation and the clinical factors of the initial and sustained erythropoietic response to continuous erythropoietin receptor activator in hemodialysis patients. ScientificWorldJournal. 2012;2012:157437. doi: 10.1100/2012/157437. Epub 2012 Apr 19.