Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)

• Status: Terminated
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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 PROCRIT® (Epoetin alfa) in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho Biotech Clinical Affairs, L.L.C.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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