Cost Utility Analysis of Erythropoietin for Anemia Treatment in Hemodialysis Patients

Completed

• Conditions: Chronic Renal Failure
• Interventions: Drug: erythropoietin

• Registration Number: NCT01049711
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Primary Completion: 2010-02
• Study Completion: 2010-09
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
erythropoietin	erythropoietin	-

Primary Outcome Measures

Name	Time	Method
The utility scores of hemodialysis (HD) patients who use EPO to maintain the Hb target level.	1 year
Cost of HD patients who use EPO to maintain the Hb target level.	1 year

Secondary Outcome Measures

Name	Time	Method
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.	lifetime horizon (Economic evaluation term)

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand