Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338000
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2006-06-16
Brief Title:
EPO-BUL-01 - Study of the Optimization of Anemia Management of EPREX Epoetin Alfa in Predialysis Patients With Chronic Renal Failure
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
An Open-Label Study of the Optimization of Anemia Management of EPREX Epoetin Alfa in Predialysis Patients With Chronic Renal Failure
Status:
COMPLETED
Status Verified Date:
2011-01
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 the study is to evaluate the effectiveness safety and clinical outcome of Epoetin alfa with dosing regime in accordance with Summary of Product Characteristics in the treatment of anemia in predialysis
Detailed Description:
Open-label non-randomized multicenter study for anemic patients with hemoglobin or11 gdl The dose of epoetin alfa is the routine dosage regimen and is in accordance of the approved SmPC Thats why the study had in general two phases - first period subcutaneous administration and second periodintravenous administration The evaluation is made in 4 visitsbaseline 2 month Visit 1 4 month Visit 2 6 month Visit 3 9 month Visit 4 Echographic evaluation - on baseline visit Visit 3 and Visit 4Baseline visit - weight arterial pressure Hemoglobin Hematocrit Erythrocytes Middle Cells Volume Middle Cells Hemoglobin Middle Cells Hemoglobin Concentration Transferrin Creatinine Clerans Visit1 Visit 2 Visit 3 Visit 4 - Hemoglobin Hematocrit Erythrocytes Middle Cells Volume Middle Cells Hemoglobin Middle Cells Hemoglobin Concentration The dosage is in routine dosing regimen the starting dose of epoetin alfa is 50 Unitskg body weight The maintaining dose depends on hematological results Administration - subcutaneous during the first period intravenous second period Duration of the study - 9 months
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