Abstract
BackgroundThis post-marketing surveillance (PMS), observational, prospective, safety study evaluated the safety, tolerability, and long-term immunogenicity of prescribed usage of Darbepoetin alfa (DA-α, manufactured by Hetero Biopharma, Hyderabad, India) in Indian patients having chronic kidney disease (CKD) with anemia.MethodsAll patients having chronic kidney disease with anemia and prescribed Hetero-Darbepoetin were the target patient population. The present study gathered the data from 503 Hetero-Darbepoetin alfa prescribed patients. This study collected information of patient demography, patient's medical history, concomitant medications, action taken with respect to Hetero-Darbepoetin-alfa, adverse events details (AE term, start date, stop date, severity, action taken, outcome, and causality), periodic hemoglobin (Hb) levels, and abnormal laboratory tests results until treatment is discontinued or the patient is lost to follow-up. Immunogenicity data were collected in 121 patients at the end of treatment and after one year.ResultsEighty-seven AEs were reported in this study and most of them were mild to moderate in intensity. No deaths or serious adverse events (SAEs) were reported in this study. Anti-drug antibodies were not detected in any subject at the end of the treatment phase and after 12 months long-term follow-up period. The baseline mean hemoglobin value was 8.34 (SD 1.24) g/dL and the last visit mean hemoglobin value was 10.42 ± 1.24 (mean ± SD) g/dL. The mean difference between baseline and last visit in hemoglobin value was 2.10 [2.00, 2.20], statistically significant (p-value <0.0001).ConclusionsThe safety and tolerability of the usage of DA-α are similar to that reported in the published literature of the innovator. No patients showed anti-drug antibodies after treatment. Additionally, the patients also showed significant improvement in hemoglobin levels, compared to baseline.
Highlights
Eighty-seven AEs were reported in this study and most of them were mild to moderate in intensity
The primary cause of renal anemia in chronic kidney disease (CKD) is the deficiency of endogenous erythropoietin mainly produced by kidneys [1]
Erythropoietin alfa is the standard of care for the treatment of anemia related to CKD undergoing dialysis and not on dialysis
Summary
The primary cause of renal anemia in chronic kidney disease (CKD) is the deficiency of endogenous erythropoietin mainly produced by kidneys [1]. DA-α has a threefold longer elimination half-life and decreased clearance compared to erythropoietin alfa. This ensures a comparatively reduced number of (DA-α) injections in the treatment of anemia in CKD patients. This post-marketing surveillance (PMS), observational, prospective, safety study evaluated the safety, tolerability, and long-term immunogenicity of prescribed usage of Darbepoetin alfa (DA-α, manufactured by Hetero Biopharma, Hyderabad, India) in Indian patients having chronic kidney disease (CKD) with anemia
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