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Erythropoietin

Generic Name
Erythropoietin
Brand Names
Procrit, Eprex, Epprex, Epoetin Alfa Hexal, Silapo, Biopoin, Abseamed, Eporatio, NeoRecormon, Epogen, Retacrit
Drug Type
Biotech
Chemical Formula
-
CAS Number
11096-26-7
Unique Ingredient Identifier
64FS3BFH5W
Background

Erythropoietin (EPO) is a growth factor produced in the kidneys that stimulates the production of red blood cells. It works by promoting the division and differentiation of committed erythroid progenitors in the bone marrow . Epoetin alfa (Epoge) was developed by Amgen Inc. in 1983 as the first rhEPO commercialized in the United States, followed by other alfa and beta formulations. Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein produced in cell culture using recombinant DNA technology and is used for the treatment of patients with anemia associated with various clinical conditions, such as chronic renal failure, antiviral drug therapy, chemotherapy, or a high risk for perioperative blood loss from surgical procedures . It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin and has the same biological activity as the endogenous erythropoietin. Epoetin alfa biosimilar, such as Retacrit (epoetin alfa-epbx or epoetin zeta), has been formulated to allow more access to treatment options for patients in the market . The biosimilar is approved by the FDA and EMA as a safe, effective and affordable biological product and displays equivalent clinical efficacy, potency, and purity to the reference product . Epoetin alfa formulations can be administered intravenously or subcutaneously.

Indication

用于肾功能不全合并的贫血,艾滋病本身或因治疗引起的贫血,恶性肿瘤伴发的贫血及风湿性贫血等。另外,为择期手术储存自体血而反复采血的患者,同时应用本品可预防发生贫血。

Associated Conditions
Anemia, Blood Loss During Surgery, Anemia caused by Zidovudine
Associated Therapies
-

Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Depression and Bipolar Disorder

Phase 2
Completed
Conditions
Mood Disorders
Interventions
First Posted Date
2009-06-09
Last Posted Date
2012-11-09
Lead Sponsor
Lars Vedel Kessing, professor, MD, DMSc.
Target Recruit Count
83
Registration Number
NCT00916552
Locations
🇩🇰

Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

Insulin Resistance and Substrate Metabolism After Acute Erythropoietin (EPO) Administration

Not Applicable
Completed
Conditions
Insulin Sensitivity
Interventions
Drug: placebo (saline)
Drug: erythropoietin
First Posted Date
2008-11-19
Last Posted Date
2009-05-29
Lead Sponsor
Aarhus University Hospital
Target Recruit Count
10
Registration Number
NCT00793767
Locations
🇩🇰

Medicinsk forsknings laboratorium, Århus C, Denmark

A Study of the Quality of Life and Treatment Response to Once Weekly Epoetin Beta (Recormon) Treatment in Anemic Participants With Solid and Lymphoid Malignancies

Phase 4
Completed
Conditions
Anemia
Interventions
First Posted Date
2008-10-21
Last Posted Date
2017-07-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
117
Registration Number
NCT00776425

A Study Comparing Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Every 4 Weeks Mircera Versus Epoetin Beta in Dialysis Patients With Chronic Renal Anemia.

Phase 3
Completed
Conditions
Anemia
Interventions
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Drug: epoetin beta
First Posted Date
2008-10-16
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
281
Registration Number
NCT00773331

A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)

Phase 4
Completed
Conditions
Chronic Renal Anemia
Interventions
First Posted Date
2008-10-16
Last Posted Date
2019-08-20
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
2825
Registration Number
NCT00773513
Locations
🇦🇺

Gosford Hospital; Renal, Gosford, New South Wales, Australia

🇭🇷

General Hospital Josip Bencevic; Department of Haemodialysis, Slavonski Brod, Croatia

🇦🇺

Renal Research Dr Simon Roger, Gosford, New South Wales, Australia

and more 193 locations

Neonatal Erythropoietin in Asphyxiated Term Newborns

Phase 1
Completed
Conditions
Hypoxic-ischemic Encephalopathy
Interventions
First Posted Date
2008-07-21
Last Posted Date
2012-11-09
Lead Sponsor
University of California, San Francisco
Target Recruit Count
24
Registration Number
NCT00719407
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.

First Posted Date
2008-07-18
Last Posted Date
2021-09-14
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
421
Registration Number
NCT00717821

Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients

Phase 3
Terminated
Conditions
Anemia
Chronic Renal Insufficiency
Interventions
First Posted Date
2008-06-19
Last Posted Date
2018-02-05
Lead Sponsor
Sandoz
Target Recruit Count
337
Registration Number
NCT00701714
Locations
🇦🇹

Diakonissen KH Salzburg, Salzburg, Austria

🇦🇹

LKH Steyr, Steyr, Austria

🇦🇹

Krankenanstalt der Stadt Wien, Wien, Austria

and more 113 locations

Randomized Trial of Erythropoietin During Cerebral Malaria

Phase 2
Conditions
Cerebral Malaria
Interventions
First Posted Date
2008-06-13
Last Posted Date
2008-06-13
Lead Sponsor
Claude Bernard University
Target Recruit Count
120
Registration Number
NCT00697164
Locations
🇲🇱

Gabriel Toure Hospital, Bamako, Mali

Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers

Not Applicable
Conditions
Iron Metabolism Disorders
Interventions
First Posted Date
2008-05-30
Last Posted Date
2008-05-30
Lead Sponsor
Rennes University Hospital
Target Recruit Count
14
Registration Number
NCT00687518
Locations
🇫🇷

Unité d'Investigation Clinique - Centre d'Investigation Clinique - Hôpital de Pontchaillou, Rennes, France

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