Frequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients
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|ClinicalTrials.gov Identifier: NCT02232113|
Recruitment Status : Completed
First Posted : September 5, 2014
Last Update Posted : September 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Anemia Inflammation Malnutrition||Drug: CERA||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Response of Continuous Erythropoietic Receptor Activator (CERA) With Different Dose Interval and the Survey for Influence Factors|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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.
changing frequency of administration from once to twice monthly under a fixed total monthly dose of CERA
- Erythropoietic response [ Time Frame: 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.
- Nutritional status and inflammatory markers [ Time Frame: every 2 months for a total of 6 months ]Nutritional status (albumin, prealbumin) and inflammatory markers [interleukin 6, tumor necrosis factor-α (TNF-α)]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232113
|Taipei Veterans General Hospital|
|Taipei, Taiwan, 112|
|Study Director:||Chih-Ching Lin, MD, PhD||Division of Nephrology and Department of Medicine, Taipei Veterans General Hospital|