Status:
TERMINATED
Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Clinical Affairs, L.L.C.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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: PROCRI...
Eligibility Criteria
Inclusion
- Chronic Kidney Disease:Glomerular filtration rate (GFR) \> 15 mL/min and \> 50 mL/min as calculated by the central lab. HB\<11 g/dL upon study enrollment. The GFR for assessment of patient eligibility will be determined using the formula derived from the Modification of Diet for Renal Disease (MDRD) Study.
Exclusion
- Pregnant or lactating women
- Presence of uncontrolled hypertension
- Known hypersensitivity to mammalian cell-derived products or human albumin
- Active gastrointestinal bleeding
- Iron overload defined as a transferrin saturation \>70% or ferritin \>1000 ng/mL
- History of frequent blood transfusions in the past 6 months
- Unstable angina or angina pectoris at rest
- Severe chronic obstructive pulmonary disease requiring routine use of supplemental oxygen
- Severe liver dysfunction that is defined by an international normalized ratio \>2.0, not caused by an anticoagulant
- Severe malnutrition
- Active hematological disease (eg, sickle cell anemia, thalassemia)
- Active malignancy (usually defined as malignancy requiring current chemotherapy or radiotherapy)
- Patients with current seizure disorder or activity
- Patients currently receiving RRT (patient can not be on dialysis or have had a kidney transplant)
- Patients who have received Epoetin Alpha within 6 weeks prior to study entry
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
1432 Patients enrolled
Trial Details
Trial ID
NCT00211120
Start Date
March 1 2002
End Date
August 1 2005
Last Update
May 18 2011
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