Frequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients

Inflammation Clinical Trial

Official title:

The Response of Continuous Erythropoietic Receptor Activator (CERA) With Different Dose Interval and the Survey for Influence Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232113
• Other study ID #: 2011-10-004IA
• Status: Completed
• Phase: Phase 4
• First received: August 3, 2014
• Last updated: September 4, 2014
• Start date: February 2012
• Est. completion date: January 2013

Study information

• Verified date: September 2014
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Inflammation
• Malnutrition

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	every 2 months for six months
Secondary	Nutritional status and inflammatory markers	Nutritional status (albumin, prealbumin) and inflammatory markers [interleukin 6, tumor necrosis factor-a (TNF-a)]	every 2 months for a total of 6 months