Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)

Correction of Hemoglobin and Outcomes In Renal Insufficiency

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.

Study Overview

• Status: Terminated
• Conditions: Anemia
• Intervention / Treatment: Drug: Epoetin Alfa

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 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
• Enrollment (Actual): 1432
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborators: Ortho Biotech Clinical Affairs, L.L.C.

Publications and helpful links

General Publications

• Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M, Reddan D; CHOIR Investigators. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med. 2006 Nov 16;355(20):2085-98. doi: 10.1056/NEJMoa065485.

Helpful Links

• Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR))

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Study Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): May 18, 2011
• Last Update Submitted That Met QC Criteria: May 17, 2011
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Anemia; Chronic Kidney Disease; Chronic Kidney Failure; Low Blood Count
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Hematinics; Epoetin Alfa
• Other Study ID Numbers: CR004588