Anemia
Conditions
Keywords
Anemia, Low Blood Count, Chronic Kidney Failure, Chronic Kidney Disease
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 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.
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.
Interventions
DRUGEpoetin Alfa
Sponsors
Ortho Biotech Clinical Affairs, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Outcome results
None listed