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

Subcutaneous (SC) Darbepoetin Alfa in Subjects With Symptomatic Congestive Heart Failure (CHF) & Anemia

Phase 2
Completed
Conditions
Congestive Heart Failure
Anemia
First Posted Date
2004-06-24
Last Posted Date
2017-02-09
Lead Sponsor
Amgen
Target Recruit Count
150
Registration Number
NCT00086086

A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

Phase 3
Completed
Conditions
Anemia
Interventions
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
First Posted Date
2004-04-16
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
324
Registration Number
NCT00081471

A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

Phase 3
Completed
Conditions
Anemia
Interventions
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
First Posted Date
2004-02-16
Last Posted Date
2016-10-26
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
313
Registration Number
NCT00077766

Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer

Phase 3
Completed
Conditions
Anemia
Leukemia
Lymphoma
Precancerous/Nonmalignant Condition
Unspecified Adult Solid Tumor, Protocol Specific
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Interventions
First Posted Date
2003-10-07
Last Posted Date
2020-08-03
Lead Sponsor
Jonsson Comprehensive Cancer Center
Target Recruit Count
14
Registration Number
NCT00070382
Locations
🇺🇸

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

Heart Failure and Anemia

Phase 2
Completed
Conditions
Heart Failure
Anemia
First Posted Date
2002-11-19
Last Posted Date
2009-08-07
Lead Sponsor
Amgen
Target Recruit Count
300
Registration Number
NCT00049985

Will Radiation/Chemotherapy Treatment of Cervical Cancer Work Better With Medication That May Improve Anemia?

Phase 2
Conditions
Anemia
Cervix Neoplasms
First Posted Date
2002-06-17
Last Posted Date
2005-06-24
Lead Sponsor
Mirhashemi, Ramin, M.D.
Target Recruit Count
64
Registration Number
NCT00039884
Locations
🇺🇸

Sylvester Comprehensive Cancer Center/JMH, Miami, Florida, United States

Anemia in Patients With a Non-Myeloid Malignancy

Phase 3
Completed
Conditions
Anemia
Neoplasms
Interventions
First Posted Date
2002-05-29
Last Posted Date
2008-09-15
Lead Sponsor
Amgen
Target Recruit Count
707
Registration Number
NCT00038064

Chemotherapy Related Anemia in Patients With Non-Myeloid Malignancies

Phase 2
Completed
Conditions
Lymphoma
Breast Neoplasms
Lung Neoplasms
Multiple Myeloma
Chronic Lymphocytic Leukemia
First Posted Date
2002-05-08
Last Posted Date
2009-05-11
Lead Sponsor
Amgen
Registration Number
NCT00036023

Chemotherapy Related Anemia

Phase 2
Completed
Conditions
Anemia
Non-Myeloid Malignancies
Interventions
First Posted Date
2002-05-06
Last Posted Date
2013-05-13
Lead Sponsor
Amgen
Target Recruit Count
120
Registration Number
NCT00035607
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