Back to resultsFrequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients
Primary Purpose
Anemia, Inflammation, Malnutrition
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
CERA
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring malnutrition, inflammation, and anemia (MIA) syndrome,, hemodialysis,, erythropoietin stimulating agent (ESA),, cost-effectiveness,, pharmacokinetics,, endothelial dysfunction
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.
Sites / Locations
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CERA
Arm 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 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.
Outcomes
Primary Outcome Measures
Erythropoietic response
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
Nutritional status and inflammatory markers
Nutritional status (albumin, prealbumin) and inflammatory markers [interleukin 6, tumor necrosis factor-α (TNF-α)]
Full Information
NCT ID
NCT02232113
First Posted
August 3, 2014
Last Updated
September 4, 2014
Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
Taipei City Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02232113
Brief Title
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
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
Taipei City Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Inflammation, Malnutrition
Keywords
malnutrition, inflammation, and anemia (MIA) syndrome,, hemodialysis,, erythropoietin stimulating agent (ESA),, cost-effectiveness,, pharmacokinetics,, endothelial dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CERA
Arm Type
Experimental
Arm 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 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.
Intervention Type
Drug
Intervention Name(s)
CERA
Other Intervention Name(s)
Full name: Continuous Erythropoietic Receptor Activator, Abbreviation : CERA, Generic name: Methoxy polyethylene glycol-epoetin beta, Brand name：Mircera®
Intervention Description
changing frequency of administration from once to twice monthly under a fixed total monthly dose of CERA
Primary Outcome Measure Information:
Title
Erythropoietic response
Description
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.
Time Frame
every 2 months for six months
Secondary Outcome Measure Information:
Title
Nutritional status and inflammatory markers
Description
Nutritional status (albumin, prealbumin) and inflammatory markers [interleukin 6, tumor necrosis factor-α (TNF-α)]
Time Frame
every 2 months for a total of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Ching Lin, MD, PhD
Organizational Affiliation
Division of Nephrology and Department of Medicine, Taipei Veterans General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22619601
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.
Results Reference
background
Links:
URL
http://www.roche.com/products/product-details.htm?type=product&id=83
Description
Used to treat patients with symptomatic anaemia associated with chronic kidney disease (CKD).
Learn more about this trial
Frequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients
We'll reach out to this number within 24 hrs