Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261521
Status:
COMPLETED
Last Update Posted:
2010-12-03
First Post:
2005-12-02
Brief Title:
A Study of the Safety and Efficacy of Long-term Correction of Anemia With Epoetin Alfa in Early Hemodialysis Patients
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Double-blind Study to Assess the Impact of Normalization of Hemoglobin Compared to Partial Correction of Hemoglobin With EPREXERYPO on Left Ventricular Structure in Early Hemodialysis Patients RWJ-22512
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study in early hemodialysis patients on dialysis 3 to 18 months is to assess the effect of correction versus partial correction of anemia using epoetin alfa on heart pumping function
Detailed Description:
Cardiovascular disease is very common among patients with end-stage renal disease This study is a long-term double-blind parallel-group multicenter study to determine the efficacy and safety of administering epoetin alfa to treat anemia patients in Group 1 or partially treat anemia patients in Group 2 in order to reduce the risk of heart failure in chronic renal failure patients on early dialysis and to improve their quality of life Efficacy of epoetin alfa will be determined by comparing between Group 1 and Group 2 the heart structure changes in left ventricle volume and mass viewed on echocardiograms development of heart failure correlation between changes in heart structure and hemoglobin level a 6-minute walking test and by 2 quality of life measures-a quality of life questionnaire and a fatigue questionnaire Safety data associated with elevation of hemoglobin will be collected and monitored throughout the study hemoglobin-related adverse events include thrombovascular events seizures and hypertension Development of antibodies to erythropoetin over long-term treatment also will be assessed by serum samples gathered over the course of the study The hypothesis of this study is that earlier and longer-term anemia intervention in patients without symptomatic heart disease or heart architecture distortions may conserve heart function and improve their quality of life and that the intervention will be well tolerated by the patients Patients not on epoetin alfa at start epoetin alfa 50 IUkg 3 times per week with increases every 4 weeks at either 25 IUkg or up to 25 of previous dose to reach target hemoglobin Hb then dose maintained Patients on or switched to epoetin alfa at start are titrated to maintain target Hb
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None