What is the target hemoglobin level in patients with Chronic Kidney Disease (CKD)?

From the Guidelines

The target hemoglobin level for patients with chronic kidney disease (CKD) should generally be in the range of 11.0 to 12.0 g/dL. This recommendation is based on the evidence from the KDOQI clinical practice guideline and clinical practice recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target 1. The selected hemoglobin target should be individualized, considering the patient's symptoms, comorbidities, and risk factors.

Rationale for Hemoglobin Target

The evidence supporting this statement includes results from 14 RCTs in dialysis patients and 15 RCTs in nondialysis patients, which compared different hemoglobin targets, including those receiving erythropoiesis-stimulating agents (ESAs) therapy 1. The Work Group considered only evidence generated from intent-to-treat analyses of trials in patients randomly assigned to either higher or lower hemoglobin targets.

Considerations for ESA Therapy

For most CKD patients with anemia, treatment with ESAs like epoetin alfa or darbepoetin alfa should be initiated when hemoglobin falls below 10 g/dL. Iron supplementation is essential before and during ESA therapy, with targets of transferrin saturation >20% and ferritin >100 ng/mL. Oral iron may be tried first, but many CKD patients require intravenous iron.

Balancing Benefits and Risks

The rationale for these targets balances the benefits of treating anemia symptoms while minimizing the risks associated with higher hemoglobin levels, which clinical trials have shown can lead to adverse outcomes despite theoretical benefits of complete anemia correction. Clinicians should avoid maintaining hemoglobin levels above 13 g/dL due to increased risks of cardiovascular events, stroke, vascular access thrombosis, and mortality without significant quality of life benefits.

Key Points

• Target hemoglobin range: 11.0 to 12.0 g/dL for patients with CKD receiving ESA therapy 1
• Individualized approach considering patient's symptoms, comorbidities, and risk factors
• Iron supplementation essential before and during ESA therapy
• Avoid maintaining hemoglobin levels above 13 g/dL due to increased risks of adverse outcomes.

From the FDA Drug Label

In controlled trials, patients with chronic kidney disease (CKD) experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks Use the lowest PROCRIT dose sufficient to reduce the need for red blood cell (RBC) transfusions

The target hemoglobin level in CKD patients should not be greater than 11 g/dL. The dosage should be the lowest sufficient to reduce the need for red blood cell transfusions, as no specific target level or dosing strategy has been identified that does not increase the risks of death, serious adverse cardiovascular reactions, and stroke 2.

From the Research

Target Hemoglobin Levels in CKD

• The optimal hemoglobin treatment target for patients with chronic kidney disease (CKD) has not been established, but several studies suggest that targeting hemoglobin levels between 9.0 and 12.0 g/dL is preferred 3, 4, 5.
• Targeting hemoglobin levels in excess of 12.0 g/dL may lead to small and not clinically meaningful improvements in health-related quality of life, and may also be associated with significant safety concerns 3.
• The 2012 Kidney Disease Improving Global Outcomes Clinical Practice Guideline for Anemia in CKD suggests avoiding ESA therapy use to maintain Hb level above 11.5 g/dL 4.
• Some studies suggest that maintaining Hb levels in the 10- to 11-g/dL range may be beneficial for patients with CKD, while others recommend a target Hb range of 9.0 to 12.0 g/dL 5, 6.
• The use of erythropoiesis-stimulating agents (ESAs) in patients with CKD should be individualized, taking into account the potential benefits and risks of treatment, and avoiding disproportionately high dosages of ESAs to achieve recommended hemoglobin targets 7.

Hemoglobin Target Ranges

• A target Hb range of 9.0 to 12.0 g/dL is suggested for adult patients with CKD 3, 4, 6.
• A target Hb level of 10g/dL is recommended for persons with CKD and cancer 5.
• The optimal Hb target range for patients undergoing chronic dialysis remains unknown, but avoiding ESA therapy use to maintain Hb level above 11.5 g/dL is recommended 4.

Safety Concerns

• Targeting hemoglobin levels in excess of 12.0 g/dL may be associated with significant safety concerns, including increased risk of cardiovascular events such as stroke, thrombosis, and death 3, 7.
• The use of ESAs in patients with CKD may also be associated with increased risk of adverse cardiac outcomes and progression of kidney disease 6, 7.