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

A Study of Repeat-Dose Subcutaneous Darbepoetin Alfa in Subjects With Congestive Heart Failure and Anemia, and a Single Dose in Healthy Age- and Sex-Matched Control Subjects

Phase 1
Completed
Conditions
Anemia
Congestive Heart Failure
First Posted Date
2005-07-06
Last Posted Date
2009-10-16
Lead Sponsor
Amgen
Registration Number
NCT00117247

Study to Evaluate Effectiveness of Aranesp®

Phase 4
Completed
Conditions
Kidney Disease
First Posted Date
2005-07-04
Last Posted Date
2011-01-21
Lead Sponsor
Amgen
Registration Number
NCT00117130

A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®

Phase 4
Completed
Conditions
Anemia
First Posted Date
2005-07-04
Last Posted Date
2009-03-25
Lead Sponsor
Amgen
Target Recruit Count
2423
Registration Number
NCT00117117

Evaluating Aranesp® in Subjects With End Stage Renal Disease onChronic Hemodialysis

Phase 4
Completed
Conditions
End Stage Renal Disease
First Posted Date
2005-07-04
Last Posted Date
2009-10-16
Lead Sponsor
Amgen
Registration Number
NCT00117104

Study of Transplant Related Anemia Treated With Aranesp® (STRATA)

Phase 4
Completed
Conditions
Anemia
First Posted Date
2005-07-04
Last Posted Date
2013-04-26
Lead Sponsor
Amgen
Registration Number
NCT00117065

A Study to Evaluate the Effectiveness of Aranesp® for Cancer Patients With Anemia

Phase 4
Completed
Conditions
Anemia
Neoplasms
First Posted Date
2005-07-04
Last Posted Date
2008-10-15
Lead Sponsor
Amgen
Target Recruit Count
1500
Registration Number
NCT00117039

Aranesp® Monthly Preference Study - 2

Phase 4
Completed
Conditions
Kidney Disease
First Posted Date
2005-07-04
Last Posted Date
2008-09-30
Lead Sponsor
Amgen
Registration Number
NCT00117078

Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis

Phase 3
Completed
Conditions
Kidney Disease
First Posted Date
2005-07-01
Last Posted Date
2008-05-05
Lead Sponsor
Amgen
Target Recruit Count
200
Registration Number
NCT00116701

A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study

Phase 3
Completed
Conditions
Anemia
Cancer
Interventions
First Posted Date
2005-06-22
Last Posted Date
2009-05-11
Lead Sponsor
Amgen
Target Recruit Count
371
Registration Number
NCT00115167

Evaluating Aranesp® for the Treatment of Anemia in African-American Subjects With Chronic Renal Failure (CRF) Receiving Hemodialysis

Phase 4
Completed
Conditions
Chronic Renal Failure
Anemia
First Posted Date
2005-05-30
Last Posted Date
2008-08-08
Lead Sponsor
Amgen
Target Recruit Count
400
Registration Number
NCT00111995
© Copyright 2025. All Rights Reserved by MedPath