Subcutaneous continuous erythropoietin receptor activators treat children with anemia, CKD
Click Here to Manage Email Alerts
Pediatric patients with anemia and chronic kidney disease can alternate between maintenance erythropoiesis-stimulating agents and subcutaneous continuous erythropoietin receptor activators every 4 weeks, according to a study.
Data published in the American Journal of Kidney Diseases showed the switch can be achieved using defined dose-conversion factors to identify the best starting dose.
Bradley A. Warady, MD, from the division of pediatric nephrology at Children's Mercy Kansas City in Missouri, and colleagues wrote, “The current study was undertaken to ascertain the optimum starting dose of [subcutaneous continuous erythropoietin receptor activator] CERA SC ... for maintenance treatment of anemia ... in pediatric patients with CKD on dialysis or not on dialysis, when switching from stable SC maintenance treatment with epoetin alfa/beta or darbepoetin alfa to CERA SC.”
In a phase 2, open label, single-arm, multicenter study, researchers explored the optimum starting dose of CERA SC in 38 pediatric patients. Patients were between 3 months and 17 years old with clinically stable renal anemia and CKD.
As CERA SC was administered every 4 weeks for 20 weeks, researchers considered the change in hemoglobin concentration for each patient as the primary outcome.
The outcome was achieved with a mean change in hemoglobin concentration between the baseline and evaluation period of plus 0.48 g/dL plus or minus 1.03 g/dL (95% CI, 0.15-0.82). Further, the concentrations remained within the target 10 g/dL to 12 g/dL range in 24 of the patients. Overall, the efficacy in key subgroups was consistent with the primary outcome.
An optional 24-week safety extension period was available to patients who completed the 20 weeks treatment with hemoglobin within 1 g/dL of baseline and within the 10 g/dL to 12 g/dL range. A total of 25 patients chose to enter the safety extension period, which revealed no new signals in safety.
“Efficacy and safety data from this study, in which nearly one-third of patients were aged [less than] 5 years, provide further valuable evidence to support the use of CERA SC in pediatric patients,” Warady and colleagues wrote. They added, “In conclusion, pediatric patients with anemia secondary to CKD who were on dialysis, or not on dialysis, could be safely and effectively switched from maintenance epoetin alfa/beta or darbepoetin alfa to CERA SC, using current dose conversion factors to determine the optimum starting dose of CERA SC [every 4 weeks] based on the weekly dose of prior ESA treatments.”
Collapse
Read more about
Click Here to Manage Email Alerts