Cost Utility Analysis of Erythropoietin for Anemia Treatment in Hemodialysis Patients

Chronic Renal Failure Clinical Trial

— CUAEPO  

Official title:

Cost-Utility Analysis of Erythropoietin for Anemia Treatmentin Thai End-Stage Renal Disease Patients With Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049711
• Other study ID #: CUAEPO
• Status: Completed
• Phase: N/A
• First received: January 11, 2010
• Last updated: September 28, 2015
• Start date: November 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic

Intervention

Drug:
• erythropoietin

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The utility scores of hemodialysis (HD) patients who use EPO to maintain the Hb target level.		1 year	Yes
Primary	Cost of HD patients who use EPO to maintain the Hb target level.		1 year	Yes
Secondary	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)	Yes

External Links

•   Completed study