Clinical trial NCT01049711: Cost Utility Analysis of Erythropoietin for Anemia Treatment in Hemodialysis Patients
Official title: Cost-Utility Analysis of Erythropoietin for Anemia Treatmentin Thai End-Stage Renal Disease Patients With Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Failure
Keywords: erythropoietin
hemodialysis
cost utility
incremental cost-effectiveness ratio
Quality adjusted life year
quality of life
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-01-14
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HD patients use EPO at least 6 months with titration of EPO therapy is permitted

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The utility scores of hemodialysis (HD) patients who use EPO to maintain the Hb target level.
timeFrame: 1 year
measure: Cost of HD patients who use EPO to maintain the Hb target level.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: lifetime horizon (Economic evaluation term)
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Faculty of Medicine, Mahidol University
name: Tanita Thaweethamcharoen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: