Frequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients

NCT02232113 | Completed Phase 4 DMC

• 1 other identifier: 2011-10-004IA
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Inflammation; Malnutrition

Keywords

malnutrition, inflammation, and anemia (MIA) syndrome,; hemodialysis,; erythropoietin stimulating agent (ESA),; cost-effectiveness,; pharmacokinetics,; endothelial dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Nutritional status and inflammatory markers

  every 2 months for a total of 6 months

Study Arms (1)

CERA

EXPERIMENTAL

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

Interventions

CERA DRUG

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

Also known as: Full name: Continuous Erythropoietic Receptor Activator, Abbreviation : CERA, Generic name: Methoxy polyethylene glycol-epoetin beta, Brand name：Mircera®

CERA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HD patients with stable hematocrit (between 30\~36%) under intravenous administration of CERA 100 μg once monthly for two months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Taipei City Hospital: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan, 112, Taiwan

Location

Related 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.

  PMID: 22619601 BACKGROUND

Related Links

• Used to treat patients with symptomatic anaemia associated with chronic kidney disease (CKD).

MeSH Terms

Conditions

Anemia; Inflammation; Malnutrition; Syndrome

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Disease

Study Officials

• Chih-Ching Lin, MD, PhD

  Division of Nephrology and Department of Medicine, Taipei Veterans General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chih-Ching Lin,M.D PhD.

Study Record Dates

• First Submitted: August 3, 2014
• First Posted: September 5, 2014
• Study Start: February 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: September 5, 2014

Record last verified: 2014-09

Locations

TW (1)