Cost Utility Analysis of Erythropoietin for Anemia Treatment in Hemodialysis Patients (CUAEPO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01049711
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : September 29, 2015
Information provided by (Responsible Party):
Mahidol University

Brief 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.

Condition or disease Intervention/treatment
Chronic Renal Failure Drug: erythropoietin

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 Type : Observational
Actual Enrollment : 152 participants
Time Perspective: Prospective
Official Title: Cost-Utility Analysis of Erythropoietin for Anemia Treatmentin Thai End-Stage Renal Disease Patients With Hemodialysis
Study Start Date : November 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
erythropoietin Drug: erythropoietin

Primary Outcome Measures :
  1. The utility scores of hemodialysis (HD) patients who use EPO to maintain the Hb target level. [ Time Frame: 1 year ]
  2. Cost of HD patients who use EPO to maintain the Hb target level. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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. [ Time Frame: lifetime horizon (Economic evaluation term) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HD patients use EPO at least 6 months with titration of EPO therapy is permitted

Inclusion Criteria:

  • Patients use EPO at least 6 months with titration of EPO therapy is permitted

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01049711

Siriraj Hospital
Bangkok, Thailand
Sponsors and Collaborators
Mahidol University
Principal Investigator: Tanita Thaweethamcharoen, Ph.D Faculty of Medicine, Mahidol University

Additional Information:
Responsible Party: Mahidol University Identifier: NCT01049711     History of Changes
Other Study ID Numbers: CUAEPO
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015

Keywords provided by Mahidol University:
cost utility
incremental cost-effectiveness ratio
Quality adjusted life year
quality of life

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Epoetin Alfa