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Completed

NCT Number: NCT01049711

Cost Utility Analysis of Erythropoietin for Anemia Treatment in Hemodialysis Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythropoietin

Drug

Primary outcomes

  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 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.

    Time frame: lifetime horizon (Economic evaluation term)

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Acronym: CUAEPO

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 14, 2010
Registry last updated
Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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