1.
Efficacy and safety of CKD-11101 (darbepoetin-alfa proposed biosimilar) compared with NESP in anaemic chronic kidney disease patients not on dialysis
Lee JH, Chung BH, Joo KW, Shin SK, Kim YL, Na KY, Do JY, Park SK, Shin BC, Lee JS, et al
Current medical research and opinion. 2018;:1-17.
Abstract
OBJECTIVE To evaluate the efficacy and safety of CKD-11101 (biosimilar darbepoetin-alfa, Chong Kun Dang Pharm.) compared with NESP(R) in treatment of anaemia in patients with chronic kidney disease not on dialysis. CLINICAL TRIAL REGISTRATION NCT03431623. METHOD In this multicentre, randomized, double-blind study, patients were treated with CKD-11101 and NESP. The efficacy evaluation period (EEP) was 24 weeks, during which patients were treated every 2 weeks. All patients who completed the EEP were treated with CKD-11101 every 2 weeks for the first four weeks and every 4 weeks for the safety evaluation period (SEP), which was from 24 weeks to 52 weeks. The primary efficacy endpoint was the change in mean haemoglobin (Hb) level from baseline to end of EEP and mean dose needed to achieve the target Hb. RESULTS The mean Hb level was increased in both groups during the EEP (both P < 0.001). The difference in mean Hb level change between the two groups was 0.01g/dL (95% CI -0.213, 0.242), indicating that CKD-11101 was equivalent to NESP. The difference in mean administration dose between groups was -1.40mcg (95% CI -6.859, 4.059) included in the equivalent range. The incidence of AEs and ADRs was not different between the two groups, and the frequency of ADRs was favourable in both groups (1.2% in CKD-11101 vs 7.7% in the NESP to CKD-11101 conversion group). CONCLUSION CKD-11101 has an equivalent therapeutic effect as NESP in chronic kidney disease patients with renal anaemia. CKD-11101 can be safely used for long-term treatment and in patients converted from NESP.
2.
A randomized crossover study of single biweekly administration of epoetin-alpha compared with darbepoetin-alpha in chronic kidney disease patients not receiving dialysis
Na HY, Lee YK, Shin SK, Yang DH, Cheon W, Park JH, Lee JH, Song JO, Jo YI
Kidney Research and Clinical Practice. 2014;33((4)):210-6.
Abstract
BACKGROUND Recent evidence demonstrates that high doses of epoetin-alpha (EPO-alpha) can be administrated at extended intervals, despite its relatively short serum half-life. However, no prospective randomized trials on the effects of extended dosing intervals of EPO-alpha compared with darbepoetin-alpha (DA-alpha) have been performed. This study was designed to investigate whether a single biweekly (Q2W) administration of a high dose of EPO-alpha is as effective as DA-alpha for anemia in chronic kidney disease (CKD) patients not receiving dialysis. METHODS Sixty non-dialysis CKD patients were equally randomized to either Q2W subcutaneous EPO-alpha (10,000 unit) or DA-alpha (50 mug) therapy groups for the first 6 weeks. After a 6-week washout period, the participants of the EPO-alpha and DA-alpha treatment groups switched to the alternate regimen for 6 weeks. The mean hemoglobin (Hb) levels after erythropoiesis stimulating agent (ESA) therapy and percentage change in Hb levels from baseline to the end of the study were analyzed. RESULTS The mean Hb levels of postESA therapy increased significantly compared with those of preESA therapy in both ESA regimens. The percentage increase in Hb levels and erythropoietin resistance index did not show a significant difference between the different ESA regimens. No difference was observed between the regimens regarding mean Hb levels after ESA therapy. Additionally, there were no serious adverse effects leading to withdrawal from treatment. CONCLUSION Biweekly high doses of EPO-alpha therapy may be equally as effective as Q2W DA-alpha therapy in maintaining target Hb levels in non-dialysis CKD patients. IS 2211-9132 IL 2211-9132