PK, PD, Safety and Immunogenicity Study of Erythropoietin of Incepta Pharmaceuticals Ltd With Eprex (Janssen-Cilag).

Summary

Erythropoietin is a glycoprotein which stimulates red blood cell production. It is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. Erythropoietin, a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous erythropoietin. Erythropoietin binds to the surface receptor of erythroid precursor cells and activates signal transduction pathways that interfere with apoptosis and stimulates erythroid cell proliferation. Recombinant human erythropoietin is a substitute for the deficiency observed in CKD, therapy of anemia often involves many other issues such as Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy, Anemic patients (hemoglobin \> 10 to \< 13 g/dL) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions, Anemia related to therapy with zidovudine in HIV-infected patients are also needed to be considered in order to effectively correct anemia, reduce costs and minimize side effects.

Timeline

Start

2025-04-24

Primary completion

2025-09-30

Completion

2025-12-31

Publications

• Results Yan X, Lowe PJ, Fink M, Berghout A, Balser S, Krzyzanski W. Population pharmacokinetic and pharmacodynamic model-based comparability assessment of a recombinant human Epoetin Alfa and the Biosimilar HX575. J Clin Pharmacol. 2012 Nov;52(11):1624-44. doi: 10.1177/0091270011421911. Epub 2011 Dec 12.
• Results Yoon S, Rhee SJ, Heo SJ, Oh TY, Yoon SH, Cho JY, Lee S, Yu KS. Comparable pharmacokinetics and pharmacodynamics of two epoetin alfa formulations Eporon(R) and Eprex(R) following a single subcutaneous administration in healthy male volunteers. Drug Des Devel Ther. 2017 Oct 27;11:3127-3135. doi: 10.2147/DDDT.S142673. eCollection 2017.
• Results Elliott S, Pham E, Macdougall IC. Erythropoietins: a common mechanism of action. Exp Hematol. 2008 Dec;36(12):1573-84. doi: 10.1016/j.exphem.2008.08.003. Epub 2008 Oct 14.
• Results Rashidi A, Garimella PS, Al-Asaad A, Kharadjian T, Torres MN, Thakkar J. Anemia Management in the Cancer Patient With CKD and End-Stage Kidney Disease. Adv Chronic Kidney Dis. 2022 Mar;29(2):180-187.e1. doi: 10.1053/j.ackd.2022.03.005.
• Results Portoles J, Martin L, Broseta JJ, Cases A. Anemia in Chronic Kidney Disease: From Pathophysiology and Current Treatments, to Future Agents. Front Med (Lausanne). 2021 Mar 26;8:642296. doi: 10.3389/fmed.2021.642296. eCollection 2021.
• Results Jelkmann W. Physiology and pharmacology of erythropoietin. Transfus Med Hemother. 2013 Oct;40(5):302-9. doi: 10.1159/000356193. Epub 2013 Jul 19.

Drugs

Indications

No indication recorded.