NCT01049711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

3 months

First QC Date

January 11, 2010

Last Update Submit

September 28, 2015

Conditions

Keywords

erythropoietinhemodialysiscost utilityincremental cost-effectiveness ratioQuality adjusted life yearquality of life

Outcome Measures

Primary Outcomes (2)

  • 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 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.

    lifetime horizon (Economic evaluation term)

Study Arms (1)

erythropoietin

Drug: erythropoietin

Interventions

erythropoietin

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HD patients use EPO at least 6 months with titration of EPO therapy is permitted

You may qualify if:

  • Patients use EPO at least 6 months with titration of EPO therapy is permitted

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Tanita Thaweethamcharoen, Ph.D

    Faculty of Medicine, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 14, 2010

Study Start

November 1, 2009

Primary Completion

February 1, 2010

Study Completion

September 1, 2010

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations