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

Evaluating Treatment of Anemia in Subjects With Non-Myeloid MalignanciesReceiving Multicycle Chemotherapy

Phase 2
Completed
Conditions
Anemia
Non-Myeloid Malignancies
Cancer
First Posted Date
2005-05-23
Last Posted Date
2013-05-08
Lead Sponsor
Amgen
Registration Number
NCT00111462

Treatment for Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis

Phase 3
Completed
Conditions
Kidney Disease
Interventions
First Posted Date
2005-05-18
Last Posted Date
2008-08-08
Lead Sponsor
Amgen
Target Recruit Count
150
Registration Number
NCT00111098

Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

Phase 3
Completed
Conditions
Cancer
Non-Myeloid Malignancies
Interventions
First Posted Date
2005-05-18
Last Posted Date
2008-02-28
Lead Sponsor
Amgen
Target Recruit Count
718
Registration Number
NCT00111137

Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Phase 3
Completed
Conditions
Anemia
Non-Myeloid Malignancies
Interventions
First Posted Date
2005-05-17
Last Posted Date
2010-01-15
Lead Sponsor
Amgen
Target Recruit Count
391
Registration Number
NCT00110955

Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis

Phase 3
Completed
Conditions
Kidney Disease
Chronic Kidney Disease
Interventions
First Posted Date
2004-11-18
Last Posted Date
2009-05-22
Lead Sponsor
Amgen
Target Recruit Count
110
Registration Number
NCT00096915

Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer

Phase 2
Completed
Conditions
Anemia
First Posted Date
2004-11-03
Last Posted Date
2009-03-13
Lead Sponsor
Amgen
Target Recruit Count
220
Registration Number
NCT00095277

A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome

Phase 2
Completed
Conditions
Myelodysplastic Syndromes
First Posted Date
2004-11-03
Last Posted Date
2010-01-15
Lead Sponsor
Amgen
Target Recruit Count
209
Registration Number
NCT00095264

Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease

Phase 3
Completed
Conditions
Kidney Disease
Chronic Kidney Disease
Interventions
First Posted Date
2004-10-11
Last Posted Date
2013-05-24
Lead Sponsor
Amgen
Target Recruit Count
1100
Registration Number
NCT00093977

Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT)

Phase 3
Completed
Conditions
Kidney Disease
Diabetes Mellitus
Anemia
Interventions
First Posted Date
2004-09-29
Last Posted Date
2022-11-08
Lead Sponsor
Amgen
Target Recruit Count
4038
Registration Number
NCT00093015

Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

Phase 3
Completed
Conditions
Anemia
Cancer
Interventions
First Posted Date
2004-09-21
Last Posted Date
2013-05-08
Lead Sponsor
Amgen
Target Recruit Count
1000
Registration Number
NCT00091858
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