Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)
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|ClinicalTrials.gov Identifier: NCT00211120|
Recruitment Status : Terminated (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.)
First Posted : September 21, 2005
Last Update Posted : May 18, 2011
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: Epoetin Alfa||Phase 4|
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 13.5 g/dL as possible (may be slightly higher or lower) or GROUP B: PROCRIT® (Epoetin alfa) therapy directed at maintaining the hemoglobin level as close to 11.3 g/dL 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® 10,000 Units (U) subcutaneously (SC) 1x / week. After 3 weekly doses, subsequent doses and dosing intervals of PROCRIT®, up to a maximum dose of 20,000 U for 36 months, will be adjusted based on an assessment of the two most recent hemoglobin values.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1432 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Correction of Hemoglobin and Outcomes In Renal Insufficiency|
|Study Start Date :||March 2002|
|Study Completion Date :||August 2005|
- The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
- All cause mortality; Myocardial infarction; Stroke; RRT;CHF, Cardiovascular and all cause hospitalizations, Change from baseline in hemoglobin, Quality of Life Scores (SF36, KDQ, LASA), transfusions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211120
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|