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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01049711
First received: January 11, 2010
Last updated: January 13, 2010
Last verified: November 2009
  Purpose

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
Chronic Renal Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cost Utility Analysis of Erythropoietin for Anemia Treatment in Hemodialysis Patients at University Hospital in Thailand

Resource links provided by NLM:


Further study details as provided by Mahidol University:

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

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: November 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049711

Locations
Thailand
Siriraj Hospital
Bangkok, Thailand
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Tanita Thaweethamcharoen, M.Pharm Faculty of Medicine, Mahidol University
  More Information

No publications provided

Responsible Party: Routine to Research Project(R2R), Faculty of Medicine, Mahidol University ,Thailand
ClinicalTrials.gov Identifier: NCT01049711     History of Changes
Other Study ID Numbers: CUAEPO
Study First Received: January 11, 2010
Last Updated: January 13, 2010
Health Authority: Thailand: Ethical Committee

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

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014