Chronic Renal FailureCUAEPONCT01049711
Cost Utility Analysis of Erythropoietin for Anemia Treatment in Hemodialysis Patients
An observational study of Chronic Renal Failure, run by Mahidol University at 1 site in Thailand.
Trial summary
To study the cost utility analysis of Erythropoietin (EPO) for maintaining the different hemoglobin (Hb) target levels in anemic hemodialysis patient in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- erythropoietin
- How many people
- 152 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2009to Sep 2010
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HD patients use EPO at least 6 months with titration of EPO therapy is permitted
Who may be able to join
- Patients use EPO at least 6 months with titration of EPO therapy is permitted
Who cannot join
- Patients under 18 years old.
- Patients who have blood transfusion for anemic treatment within 6 months before EPO treatment and before the study starts
- Patients who change the modality of dialysis
- Patients who switch to other anemia treatment method between the study
- Patients who cannot answer the questionnaire and are not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost-Utility Analysis of Erythropoietin for Anemia Treatmentin Thai End-Stage Renal Disease Patients With Hemodialysis
To study the cost utility analysis of Erythropoietin (EPO) for maintaining the different hemoglobin (Hb) target levels in anemic hemodialysis patient in routine clinical practice.
Read the detailed description
In Thailand, the studies that were conducted to find the most useful target Hb have not included the cost effectiveness and/or cost utility analyses. The level at which quality of life is maximized and risk is minimized would be the optimal target. Dialysis patients carry higher risk of death than general population. Anemia is the common complication found in dialysis patients that could lead to mortality. Risk of anemia is occurred in HD patients more than CAPD patients because blood loss is less marked and residual renal function maybe better preserved in patients who receive peritoneal dialysis.Although EPO has been included in the National List of Essential Drugs (NLED) for the treatment of anemia caused by end stage renal disease for maintaining the target hemoglobin but the cost of EPO is so expensive. Cost utility analysis is economic technique for assessing the efficiency of healthcare intervention measuring combined outcomes as the effectiveness, i.e., survival and quality of life in combination as quality adjusted life years (QALYs).This study is a benefit measure at the care giving level by using as a part of planning patient management program and at the policy level for decision making.
- Conditions
- Chronic Renal Failure
- Being tested
- erythropoietin
- Keywords
- erythropoietin, hemodialysis, cost utility, incremental cost-effectiveness ratio, Quality adjusted life year, quality of life
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythropoietinDrug
| Study group | Role | What they receive |
|---|---|---|
| erythropoietin | Not described Receives: Drug: erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The utility scores of hemodialysis (HD) patients who use EPO to maintain the Hb target level.
Measured: 1 year
Cost of HD patients who use EPO to maintain the Hb target level.
Measured: 1 year
Secondary outcomes (1)
The incremental cost-effectiveness ratio (calculated as the ratio between the incremental differences in costs and QALYs associated with 2 alternative treatments) of EPO at the different Hb target levels in HD patients in routine clinical practice.
Measured: lifetime horizon (Economic evaluation term)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionFeb 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanita Thaweethamcharoen, Ph.D, Principal investigator, Faculty of Medicine, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049711
- Sponsor's protocol ID
- CUAEPO
- Acronym
- CUAEPO
- Status last verified
- Sep 2015
- First submitted
- 11 Jan 2010
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Utility Analysis of Erythropoietin for Anemia Treatmentin Thai End-Stage Renal Disease Patients With Hemodialysis
- ClinicalTrials.gov ID
- NCT01049711
- Acronym / sponsor ID
- CUAEPO / CUAEPO
- Conditions
- Chronic Renal Failure
- Keywords
- erythropoietin, hemodialysis, cost utility, incremental cost-effectiveness ratio, Quality adjusted life year, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 Jan 2010 (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.
To study the cost utility analysis of Erythropoietin (EPO) for maintaining the different hemoglobin (Hb) target levels in anemic hemodialysis patient in routine clinical practice.
Detailed description
In Thailand, the studies that were conducted to find the most useful target Hb have not included the cost effectiveness and/or cost utility analyses. The level at which quality of life is maximized and risk is minimized would be the optimal target. Dialysis patients carry higher risk of death than general population. Anemia is the common complication found in dialysis patients that could lead to mortality. Risk of anemia is occurred in HD patients more than CAPD patients because blood loss is less marked and residual renal function maybe better preserved in patients who receive peritoneal dialysis.Although EPO has been included in the National List of Essential Drugs (NLED) for the treatment of anemia caused by end stage renal disease for maintaining the target hemoglobin but the cost of EPO is so expensive. Cost utility analysis is economic technique for assessing the efficiency of healthcare intervention measuring combined outcomes as the effectiveness, i.e., survival and quality of life in combination as quality adjusted life years (QALYs).This study is a benefit measure at the care giving level by using as a part of planning patient management program and at the policy level for decision making.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| erythropoietin | – | Drug: erythropoietin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HD patients use EPO at least 6 months with titration of EPO therapy is permitted
Key inclusion criteria (1 listed)
- Patients use EPO at least 6 months with titration of EPO therapy is permitted
Key exclusion criteria (5 listed)
- Patients under 18 years old.
- Patients who have blood transfusion for anemic treatment within 6 months before EPO treatment and before the study starts
- Patients who change the modality of dialysis
- Patients who switch to other anemia treatment method between the study
- Patients who cannot answer the questionnaire and are not willing to participate in the study
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 |
|---|---|---|
| erythropoietin | Drug | erythropoietin |
Primary outcome
The utility scores of hemodialysis (HD) patients who use EPO to maintain the Hb target level.
Time frame: 1 year
Cost of HD patients who use EPO to maintain the Hb target level.
Time frame: 1 year
1 secondary outcome
The incremental cost-effectiveness ratio (calculated as the ratio between the incremental differences in costs and QALYs associated with 2 alternative treatments) of EPO at the different Hb target levels in HD patients in routine clinical practice.
Time frame: lifetime horizon (Economic evaluation term)
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 29 Sep 2015.
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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.
Tanita Thaweethamcharoen, Ph.D principal investigator
Faculty of Medicine, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Failure, run by Mahidol University at 1 site in Thailand.
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 5 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 29 Sep 2015. 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 Thailand. 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.
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?
The utility scores of hemodialysis (HD) patients who use EPO to maintain the Hb target level. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2015.