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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
Sponsor:
Collaborator:
Taipei City Hospital
Information provided by (Responsible Party):
vghtpe user, 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.


Condition or disease Intervention/treatment Phase
Anemia Inflammation Malnutrition Drug: CERA Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: 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.
Drug: CERA
changing frequency of administration from once to twice monthly under a fixed total monthly dose of CERA
Other Names:
  • Full name: Continuous Erythropoietic Receptor Activator
  • Abbreviation : CERA
  • Generic name: Methoxy polyethylene glycol-epoetin beta
  • Brand name:Mircera®




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232113


Locations
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Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Taipei City Hospital
Investigators
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Study Director: Chih-Ching Lin, MD, PhD Division of Nephrology and Department of Medicine, Taipei Veterans General Hospital
Publications:
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Responsible Party: vghtpe user, Chih-Ching Lin,M.D PhD., Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT02232113    
Other Study ID Numbers: 2011-10-004IA
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014
Keywords provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:
malnutrition, inflammation, and anemia (MIA) syndrome,
hemodialysis,
erythropoietin stimulating agent (ESA),
cost-effectiveness,
pharmacokinetics,
endothelial dysfunction
Additional relevant MeSH terms:
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Malnutrition
Inflammation
Pathologic Processes
Nutrition Disorders