MedPath

Darbepoetin alfa

Generic Name
Darbepoetin alfa
Brand Names
Aranesp
Drug Type
Biotech
CAS Number
209810-58-2
Unique Ingredient Identifier
15UQ94PT4P
Background

Human erythropoietin with 2 aa substitutions to enhance glycosylation (5 N-linked chains), 165 residues (MW=37 kD). Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.

Indication

For the treatment of anemia (from renal transplants or certain HIV treatment)

Associated Conditions
Anemia

Treatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy

Phase 2
Completed
Conditions
Gynecological Malignancies
Genital Neoplasms, Female
Anemia
First Posted Date
2005-07-21
Last Posted Date
2007-12-24
Lead Sponsor
Amgen
Registration Number
NCT00121030

Efficacy Study: Darbepoetin Alfa for the Treatment of Anemia in Patients With Chronic Kidney Disease

Phase 3
Completed
Conditions
Anemia
Kidney Disease
Interventions
First Posted Date
2005-07-21
Last Posted Date
2008-02-28
Lead Sponsor
Amgen
Target Recruit Count
446
Registration Number
NCT00121602

Treatment for Patients Suffering From Anemia Due to Chemotherapy

Phase 2
Completed
Conditions
Breast Cancer
Anemia
First Posted Date
2005-07-19
Last Posted Date
2007-12-24
Lead Sponsor
Amgen
Registration Number
NCT00120692

Treatment for Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy

Phase 2
Completed
Conditions
Neoplasms
Anemia
First Posted Date
2005-07-19
Last Posted Date
2009-03-25
Lead Sponsor
Amgen
Target Recruit Count
204
Registration Number
NCT00120705

Treatment for Patients With Non-Small Cell Lung Cancer Who Developed Anemia Due to Chemotherapy

Phase 2
Completed
Conditions
Non-Small Cell Lung Cancer
Anemia
First Posted Date
2005-07-19
Last Posted Date
2007-12-24
Lead Sponsor
Amgen
Registration Number
NCT00120679

A Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa

Phase 3
Completed
Conditions
Small Cell Lung Cancer
Interventions
First Posted Date
2005-07-14
Last Posted Date
2008-08-08
Lead Sponsor
Amgen
Target Recruit Count
600
Registration Number
NCT00119613

Darbepoetin Alfa Treatment of Anemia in Hemodialysis Subjects

Phase 3
Completed
Conditions
Anemia
First Posted Date
2005-07-14
Last Posted Date
2007-12-28
Lead Sponsor
Amgen
Registration Number
NCT00119587

A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Phase 3
Completed
Conditions
Anemia
Non-Myeloid Malignancies
Interventions
First Posted Date
2005-07-12
Last Posted Date
2013-04-29
Lead Sponsor
Amgen
Target Recruit Count
705
Registration Number
NCT00118638

A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy

Phase 3
Completed
Conditions
Anemia
First Posted Date
2005-07-08
Last Posted Date
2007-12-28
Lead Sponsor
Amgen
Registration Number
NCT00117624

Impact of Darbepoetin Alfa on Exercise Tolerance and Left Ventricular Structure in Subjects With Symptomatic Congestive Heart Failure (CHF) and Anemia

Not Applicable
Completed
Conditions
Congestive Heart Failure
Anemia
First Posted Date
2005-07-06
Last Posted Date
2010-12-03
Lead Sponsor
Amgen
Registration Number
NCT00117234
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