Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)

Phase 4TerminatedNCT00211120

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.1,432 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,432

Conditions

Anemia

Interventions

Epoetin AlfaDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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