Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211120
Status:
TERMINATED
Last Update Posted:
2011-05-18
First Post:
2005-09-13
Brief Title:
Correction of Hemoglobin and Outcomes in Renal Insufficiency CHOIR
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Correction of Hemoglobin and Outcomes In Renal Insufficiency
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stopped by the DSMB due to a trend toward more adverse events in the higher hemoglobin Hb arm and 5 chance that the study would show benefit for higher Hb
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 is to compare the outcomes of patients with chronic kidney disease CKD randomly assigned to 2 treatment groups which differ only in their targeted hemoglobin levels This study will test the primary hypothesis that the level of anemia correction with once weekly dosing of PROCRITÂ Epoetin alfa in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity
Detailed Description:
This is a prospective open-label randomized multi-center study in patients with CKD Patients who meet the selection criteria will be randomly assigned to one of two treatment arms GROUP A PROCRIT Epoetin alfa therapy directed at maintaining the hemoglobin level as close to 135 gdL as possible may be slightly higher or lower or GROUP B PROCRIT Epoetin alfa therapy directed at maintaining the hemoglobin level as close to 113 gdL as possible may be slightly higher or lower
Patients will receive weekly doses of PROCRIT Epoetin alfa Subsequent doses of PROCRIT will be given weekly as needed with dose adjustments made to maintain the hemoglobin Hb as close to the target level as possible until the initiation of Renal Replacement Therapy RRT or 36 months whichever comes first
The purpose of this study is to compare the outcomes of patients with CKD randomly assigned to 2 treatment groups which differ only in their targeted hemoglobin levels This study will test the primary hypothesis that the level of anemia correction with once weekly dosing of PROCRIT Epoetin alfa in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity Patients will receive a starting dose of PROCRIT 10000 Units U subcutaneously SC 1x week After 3 weekly doses subsequent doses and dosing intervals of PROCRIT up to a maximum dose of 20000 U for 36 months will be adjusted based on an assessment of the two most recent hemoglobin values
Patients will receive weekly doses of PROCRIT Epoetin alfa Subsequent doses of PROCRIT will be given weekly as needed with dose adjustments made to maintain the hemoglobin Hb as close to the target level as possible until the initiation of Renal Replacement Therapy RRT or 36 months whichever comes first
The purpose of this study is to compare the outcomes of patients with CKD randomly assigned to 2 treatment groups which differ only in their targeted hemoglobin levels This study will test the primary hypothesis that the level of anemia correction with once weekly dosing of PROCRIT Epoetin alfa in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity Patients will receive a starting dose of PROCRIT 10000 Units U subcutaneously SC 1x week After 3 weekly doses subsequent doses and dosing intervals of PROCRIT up to a maximum dose of 20000 U for 36 months will be adjusted based on an assessment of the two most recent hemoglobin values
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