What is the target hemoglobin level with epoetin alfa (Procrit) in patients with Chronic Kidney Disease (CKD) not on dialysis?

From the Guidelines

For CKD patients not on dialysis receiving Procrit (epoetin alfa), the target hemoglobin level should be in the range of 11.0 to 12.0 g/dL. This recommendation is based on the most recent and highest quality study available, which suggests that this target range is associated with improved patient outcomes, including reduced risk of left ventricular hypertrophy, improved quality of life, and decreased mortality 1. The evidence from this study, published in 2007, supersedes earlier guidelines and recommendations, and provides a clear and concise target range for hemoglobin levels in CKD patients not on dialysis.

Some key points to consider when targeting this hemoglobin range include:

• Initiating treatment when hemoglobin falls below 10 g/dL to avoid blood transfusions and minimize cardiovascular risks
• Dosing typically starts at 50-100 units/kg three times weekly, with adjustments made based on hemoglobin response
• Hemoglobin should be monitored every 2-4 weeks during initiation and dose adjustment, then monthly once stable
• Maintaining iron stores (transferrin saturation ≥20% and ferritin ≥100 ng/mL) to ensure optimal response to Procrit
• Avoiding higher hemoglobin targets (>13 g/dL), which have been associated with increased risk of cardiovascular events, stroke, vascular access thrombosis, and mortality without providing additional symptomatic benefit 1.

It's also important to individualize treatment based on the patient's symptoms, comorbidities, and rate of hemoglobin decline, with careful consideration of risks versus benefits. By targeting a hemoglobin range of 11.0 to 12.0 g/dL, healthcare providers can help improve patient outcomes and reduce the risk of complications associated with anemia in CKD patients not on dialysis.

From the FDA Drug Label

Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 – 14 g/dL) to lower targets (9 – 11.3 g/dL), PROCRIT and other ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups CHOIR: A randomized, prospective trial, 1432 patients with anemia due to CKD who were not undergoing dialysis and who had not previously received epoetin alfa therapy were randomized to epoetin alfa treatment targeting a maintenance hemoglobin concentration of either 13.5 g/dL or 11.3 g/dL.

The target hemoglobin with Procrit in CKD patients not on dialysis is less than or equal to 11 g/dL 2.

• The recommended target is not to exceed 11 g/dL to minimize the risk of serious adverse cardiovascular reactions.
• Higher targets (13-14 g/dL) have been associated with increased risks of death, myocardial infarction, stroke, and other thromboembolic events.

From the Research

Target Hemoglobin with Procrit in CKD Patients Not on Dialysis

• The target hemoglobin level for CKD patients not on dialysis is not explicitly stated in the provided studies, but we can look at the hemoglobin levels achieved in the studies as a reference.
• In the study by 3, the mean hemoglobin level increased from 9.1 g/dl to 11.6 g/dl after treatment with epoetin alfa.
• The study by 4 suggests that anemia is diagnosed when the hemoglobin is <12 g/dL in a man or a postmenopausal woman, or <11 g/dL in a premenopausal woman.
• The study by 5 compared two target hemoglobin groups: a high Hb group (11.0-13.0g/dL) and a low Hb group (9.0-11.0g/dL), and found that patients with a higher Hb target had better outcomes with respect to quality of life and left ventricular mass index.

Hemoglobin Targets and Outcomes

• The study by 5 found that targeting a higher hemoglobin level (11.0-13.0g/dL) was associated with improved quality of life and left ventricular mass index, without increasing the risk of cardiovascular adverse events.
• The study by 3 found that treatment with epoetin alfa was associated with significant improvements in functional status and quality of life, with a mean hemoglobin level of 11.6 g/dl.
• The study by 6 found that variations in hemoglobin concentrations occurred during maintenance therapy administered at extended dosing intervals, resulting in the resumption of shorter dosing intervals in the majority of patients.

Considerations for Hemoglobin Targets

• The study by 7 highlights the importance of iron deficiency in the pathophysiology of anemia in CKD, and the need for adequate iron stores to achieve optimal hemoglobin levels.
• The study by 4 notes that poor response to treatment with erythropoiesis-stimulating agents can be due to many factors, including iron deficiency, inflammation, and continued blood loss.