Conversion of Darbepoetin to Low Doses of CERA Maintains Hemoglobin Levels in Non-Dialysis Chronic Kidney Disease Patients

Abstract

Background/Aims: Finding the lowest effective dose of erythropoietin-stimulating agents is critical in the management of renal anemia. We evaluated the efficacy of converting darbepoetin to CERA at doses lower than those usually recommended. Methods: We selected consecutive non-dialysis chronic kidney disease patients treated with darbepoetin doses ≤40 µg/week in absence of iron deficiency, recent blood transfusion, bleeding, neoplasia, myocardial infarction/stroke in the last 3 months. Darbepoetin ≤20 µg/week was shifted to CERA 75 µg/month, while darbepoetin 21–40 µg/week to CERA 100 µg/month. Primary endpoint was the change in hemoglobin (Hb goal, 11–13 g/dl) at month 3, 6, 9 and 12. Results: Studied patients (n = 37) were aged 70 ± 13 years and GFR was 30 ± 12 ml/min/1.73 m²; prevalence of males, diabetes and prior cardiovascular disease was 43, 45 and 40%, respectively. Before switching, efficacy population received darbepoetin 18 ± 10 µg/week with 28 patients receiving ≤20 µg/week. Prevalence of Hb goal at baseline was 75.7% and did not change at months 3 (70.3%), 6 (70.3%), 9 (72.2%), and 12 (80.0%). CERA dose remained unchanged during the study (81 ± 11, 82 ± 16, 91 ± 30, 90 ± 54 and 88 ± 61 µg/month). Out of the 438 visits performed, CERA dose was increased in 52 (11.9%) and reduced in 36 (8.2%) visits. Blood pressure, Hb, GFR, transferrin saturation and ferritin did not change. Conclusions: In chronic kidney disease patients treated with darbepoetin doses ≤40 µg/week, CERA can be efficaciously used at doses lower than those recommended.

Monthly CERA Treatment Maintains Stable Hemoglobin Levels in Routine Clinical Practice of Peritoneal Dialysis Patients

“…In clinical practice, lower and better stratification of the initial CERA dosage has been proved compared with the doses recommended in the SPC. 25 The information provided by the present study suggests that CERA is effective even at dose levels lower than the dosage recommended by SPC. So, mean Hb levels remained close to 12 g/dL over the whole evaluation period.…”

“…Regarding this issue, the prescription of CERA doses below recommended values has been reported in several studies 13,25 and it was considered effective in maintaining Hb levels in CKD patients not on dialysis. 25 In peritoneal dialysis patients, the need for frequent punctures could diminish their quality of life and increase the loss of adherence to treatment. The prolonged half-life of CERA could be beneficial in preventing these problems in peritoneal dialysis patients.…”

Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Predialysis Patients

“…Data from clinical studies (8-13) suggest safe and effective use of C.E.R.A. every 2-4 weeks and once-monthly for correction and maintenance therapy, respectively, in anemic predialysis (8,10,(12)(13)(14)(15)(16)(17) or dialysis (9,11,(18)(19)(20) CKD patients.…”

“…Switching of treatment from once weekly darbopoetin alpha to monthly C.E.R.A. was reported to be associated with an increase in the rate for success in correction of anemia in a year from 75.7% to 80% in anemic predialysis patients (16).…”

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“…16 Another study in CKD patients not on dialysis who changed from onceweekly darbepoetin alfa to once-monthly CERA also reported hemoglobin levels from 110 to 130 g/L in 65% to 80% patients. 39 In another observational study, CERA administration under clinical practice conditions enabled anemia to be controlled in kidney transplant recipients. 29 In patients who had not received erythropoietin-stimulating agents, starting CERA promoted increased hemoglobin levels to ≥ 110 g/L in 95% patients without the need for blood transfusions.…”