Investigational Product/ Process /Intervention
Research Description/ Research Lay Summary
Prospective study of epoietin utilisation, haemoglobin outcomes and survival of dialysis patients in Malaysia from 1997 to 2005. Assuming constant funding for epoietin, the study will estimate the increase in mean epoietin dose should its cost decrease with the introduction of low cost epoietin. A natural logarithmic regression model will be used to approximate the pharmacodynamics of epoietin. Mortality impact of higher haemoglobin will be estimated by a parametric Weibull regression model.
Research Keyword
Anaemia, Dialysis, Generic substitution, Erythropoietin, Cost saving
Research Objective
1. to analyze the impact of low cost biogeneric erythropoietin on patientsÂ’ hemoglobin and mortality outcomes
2. to determine the utilization of erythropoietin in our dialysis population
3. to estimate the potential cost savings from the introduction of low cost biogeneric erythropoietin in our dialysis population
4. to estimate the number of additional lives saved through the availability of low cost biogeneric erythropoietin.
Expected / Actual Date Study Starts - First Enrolment of subject / Collecting data
May, 11 2006
Expected / Actual Date Study Completed
Expected / Actual Duration of Study Enrollment / Data Collection
Subject (Sample Size) Description
Age Range :
Gender :
Biospecimen Collection & Archiving
-
Current Study Status
Not Yet Recruiting
Principal Investigator Information
Dr Shanthi Varatharajan
JABATAN KESIHATAN WILAYAH PERSEKUTUAN KUALA LUMPUR & PUTRAJAYA
Sponsor
Clinical Research Centre
Ethical Application Status
Individual Clinical Trial Participant–level Data of Individual Participant Data (IPD) Sharing