CKD-11101 Phase 3 SC Study

Summary

The aim of this study was to compare and evaluate efficacy and safety of subcutaneous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia not on dialysis.

Timeline

Start

2015-05

Primary completion

2017-02

Completion

2017-08

Publications

• Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
• Lee JH, Ha Chung B, Joo KW, Shin SK, Kim YL, Na KY, Do JY, Park SK, Shin BC, Lee JS, Kim YW, Kim SW, Lee KW, Kang GW, An WS, Shin GT, Han S, Yang CW. Efficacy and safety of CKD-11101 (darbepoetin-alfa proposed biosimilar) compared with NESP in anaemic chronic kidney disease patients not on dialysis. Curr Med Res Opin. 2019 Jun;35(6):1111-1118. doi: 10.1080/03007995.2018.1560134. Epub 2019 Jan 17.

Drugs

Indications