From the Guidelines
In patients with CKD stage V, a hemoglobin level below 10 g/dL is considered critical, as levels below this threshold have been associated with worse patient outcomes, including decreased survival and increased risk of left ventricular hypertrophy and cardiovascular events. According to the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) clinical practice guidelines for anemia of chronic kidney disease, update 2000 1, the target range for hemoglobin should be between 11 g/dL and 12 g/dL. However, several pieces of evidence suggest that patient outcomes are worse when the hemoglobin level is 10 g/dL or lower, with survival declining as the hemoglobin level decreases below a range of 10 to 11 g/dL.
Some key points to consider in managing anemia in CKD stage V patients include:
- The use of erythropoiesis-stimulating agents (ESAs) such as epoetin alfa or darbepoetin alfa to increase hemoglobin levels
- Iron supplementation to maintain transferrin saturation and ferritin levels
- The potential need for blood transfusions in cases of severe anemia with symptoms such as chest pain, severe fatigue, or shortness of breath
- The risks associated with blood transfusions, including iron overload and allosensitization
It is essential to note that the anemia literature in CKD patients does not distinguish between sexes, and subsequent hemoglobin levels will apply to both males and females. The NKF-KDOQI guidelines recommend a target hemoglobin range of 11 g/dL to 12 g/dL, but levels below 10 g/dL are considered critical and require prompt attention to improve patient outcomes. As stated in the guidelines, "Survival of dialysis patients declines as the Hct decreases below a range of 30% to 33%" 1, which corresponds to a hemoglobin level of approximately 10 g/dL.
From the FDA Drug Label
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 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 Placebo group patients also received darbepoetin alfa when their hemoglobin levels were below 9 g/dL
A critical hemoglobin level for patients with CKD, stage V is not explicitly defined in the provided drug labels. However, the labels suggest that targeting a hemoglobin level of greater than 11 g/dL may increase the risk of serious adverse cardiovascular reactions, and that a hemoglobin level below 9 g/dL may require intervention with ESAs such as darbepoetin alfa or epoetin alfa 2, 3, 3.
- Key points:
- Hemoglobin targets above 11 g/dL may increase cardiovascular risk
- Hemoglobin levels below 9 g/dL may require ESA intervention
- No explicit definition of a "critical" hemoglobin level is provided in the labels
From the Research
Hemoglobin Levels in CKD Stage V
- A critical hemoglobin level in patients with CKD stage V is not explicitly defined, but several studies provide guidance on target hemoglobin levels in CKD patients.
- According to 4, the target hemoglobin level in CKD patients should not exceed 12 g/dL, as higher levels may increase the risk of death and cardiovascular complications.
- The Anemia Group of the European Renal Best Practice recommends a target hemoglobin level of 11-12 g/dL in CKD patients, with a risk-benefit evaluation for individual patients 5.
- A study on non-dialysis CKD patients with anemia found that initiating erythropoietin therapy when hemoglobin levels decreased below 11 g/dL, but not below 10 g/dL, could be more effective at reducing the risk of renal events 6.
- Another study found that hemoglobin levels below 9 g/dL were associated with a higher risk of renal events in non-dialysis CKD patients with anemia 6.
Implications for CKD Stage V Patients
- CKD stage V patients with hemoglobin levels below 9 g/dL may be at higher risk for renal events and cardiovascular complications.
- Targeting a hemoglobin level of 11-12 g/dL may be appropriate for CKD stage V patients, but individualized treatment decisions should be made based on patient-specific factors.
- Erythropoiesis-stimulating agents (ESAs) can be effective in increasing hemoglobin levels in CKD patients, but the choice of ESA and dosing regimen should be carefully considered 7, 5, 8.