AnemiaPhase 4NCT02232113
Frequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients
A Phase 4 study testing CERA in people with Anemia and Inflammation, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anemia, Inflammation, Malnutrition
- What is being tested?
- CERA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2012to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HD patients with stable hematocrit (between 30~36%) under intravenous administration of CERA 100 μg once monthly for two months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Response of Continuous Erythropoietic Receptor Activator (CERA) With Different Dose Interval and the Survey for Influence Factors
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.
Read the 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.
- Conditions
- Anemia, Inflammation, Malnutrition
- Being tested
- CERA
- Keywords
- malnutrition, inflammation, and anemia (MIA) syndrome,, hemodialysis,, erythropoietin stimulating agent (ESA),, cost-effectiveness,, pharmacokinetics,, endothelial dysfunction
- Medical subject headings
- Anemia, Inflammation, Malnutrition, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CERADrug
Also called Full name: Continuous Erythropoietic Receptor Activator, Abbreviation : CERA, Generic name: Methoxy polyethylene glycol-epoetin beta, Brand name：Mircera®
changing frequency of administration from once to twice monthly under a fixed total monthly dose of CERA
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CERA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every 2 months for six months
Secondary outcomes (1)
Nutritional status and inflammatory markers
Nutritional status (albumin, prealbumin) and inflammatory markers [interleukin 6, tumor necrosis factor-α (TNF-α)]
Measured: every 2 months for a total of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startFeb 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Taipei City Hospital
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Chih-Ching Lin, MD, PhD, Study director, Division of Nephrology and Department of Medicine, Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232113
- Sponsor's protocol ID
- 2011-10-004IA
- Status last verified
- Sep 2014
- First submitted
- 3 Aug 2014
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22619601
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Response of Continuous Erythropoietic Receptor Activator (CERA) With Different Dose Interval and the Survey for Influence Factors
- ClinicalTrials.gov ID
- NCT02232113
- Acronym / sponsor ID
- 2011-10-004IA
- Conditions
- Anemia, Inflammation, Malnutrition
- Keywords
- malnutrition, inflammation, and anemia (MIA) syndrome,, hemodialysis,, erythropoietin stimulating agent (ESA),, cost-effectiveness,, pharmacokinetics,, endothelial dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Taipei City Hospital
- Study start
- Feb 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CERA | Experimental | Drug: CERAWe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HD patients with stable hematocrit (between 30~36%) under intravenous administration of CERA 100 μg once monthly for two months.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CERAAlso: Full name: Continuous Erythropoietic Receptor Activator, Abbreviation : CERA, Generic name: Methoxy polyethylene glycol-epoetin beta, Brand name：Mircera®changing frequency of administration from once to twice monthly under a fixed total monthly dose of CERA | Drug | CERA |
Primary outcome
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.
1 secondary outcome
Nutritional status and inflammatory markers
Time frame: every 2 months for a total of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
- Background: PubMed 22619601Liu 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.
- Used to treat patients with symptomatic anaemia associated with chronic kidney disease (CKD).Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih-Ching Lin, MD, PhD study director
Division of Nephrology and Department of Medicine, Taipei Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CERA in people with Anemia and Inflammation, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythropoietic response (time frame: every 2 months for six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02232113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2014.