CERA Effective for Pediatric Hemodialysis Patients With Anemia
The safety profile of CERA is similar for children as for adults.
Continuous erythropoietin receptor activator–methoxy polyethylene glycol-epoetin beta (CERA) effectively maintains hemoglobin levels in pediatric hemodialysis (HD) patients with stable anemia who are switching from other erythropoiesis-stimulating agents (ESAs).
In a study, Michel Fischbach, MD, of Centre Hospitalier Universitaire Hautepierre in France, and collaborators tested two conversion factors in 64 pediatric HD patients aged 6–17 years transferring from darbepoetin or epoetin alfa/beta to intravenous CERA. Group 1 was treated with an intermediate conversion factor: a starting dose of 4 µg CERA every 4 weeks for each weekly dose of 250 IU epoetin alfa/beta or 1.1 µg darbepoetin. Group 2, the high conversion factor group, received a double dose: a starting dose of 4 µg CERA every 4 weeks for each weekly dose of 125 IU epoetin alfa/beta or 0.55 µg darbepoetin.
The high conversion factor proved more effective at maintaining hemoglobin levels within a target of 10.0–12.0 g/dL during both the 16-week dose-titration and the 4-week evaluation period, according to results published online ahead of print in the Clinical Journal of the American Society of Nephrology. Of group 2 patients, 81% maintained hemoglobin within 10.0–12.0 g/dL and 75% kept their hemoglobin levels within 1.0 g/dL of baseline. At last observation, 70% had target hemoglobin levels, and 62% had levels within 1.0 g/dL of baseline. For group 2, the adjusted mean change in hemoglobin from baseline was -0.09 g/dL. Consistent results were observed in subgroup analyses by age groups (6–11 and 12–17 years) and by previous ESA.
About half of the patients entered a 1-year safety extension period. No new safety signals from CERA were identified compared with adult patients. During the core trial period, 77% experienced one or more adverse events. Headache, nasopharyngitis, and hypertension were the most common. One quarter had a serious adverse event. Only 2 cases (1 each of arteriovenous fistula thrombosis and thrombosis in device) were considered related to treatment.
“In conclusion, pediatric patients with CKD and anemia undergoing hemodialysis can be safely and effectively switched from weekly maintenance treatment with epoetin alfa/beta or darbepoetin to 4-weekly intravenous injections of C.E.R.A., using the conversion factor defined in this study,” Dr Fischbach and the team stated.
Fischbach M, W€uhl E, Meyer Reigner SC, Morgan Z, and Schaefer F. Efficacy and long-term safety of C.E.R.A. maintenance in pediatric hemodialysis patients with anemia of CKD. Clin J Am Soc Nephrol. doi: 10.2215/CJN.03570417 [Epub November 2017]