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

PRevention of End Stage Kidney Disease by Darbepoetin Alfa In Chronic Kidney Disease Patients With nondiabeTic Kidney Disease

Phase 3
Completed
Conditions
Diabetes
Chronic Kidney Disease
Interventions
First Posted Date
2012-04-19
Last Posted Date
2018-04-18
Lead Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Target Recruit Count
476
Registration Number
NCT01581073
Locations
🇯🇵

Showa University School of Medicine, Shinagawa, Tokyo, Japan

Intracoronary Darbepoetin-alpha to Reduce The Infarct Size and Post-Infarct Remodeling

Phase 2
Completed
Conditions
Myocardial Infarction
Interventions
Drug: Control Saline
First Posted Date
2012-02-24
Last Posted Date
2015-06-19
Lead Sponsor
Seoul National University Bundang Hospital
Target Recruit Count
80
Registration Number
NCT01538771
Locations
🇰🇷

Seoul National University Bundang Hospital, Seongnam, Korea, Republic of

A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients

Phase 4
Completed
Conditions
Moderate to Severe Secondary Hyperparathyroidism
Stage 5 Chronic Kidney Diseases
Interventions
First Posted Date
2012-01-10
Last Posted Date
2021-07-30
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
65
Registration Number
NCT01506947

A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome

Phase 2
Completed
Conditions
MDS
First Posted Date
2011-12-22
Last Posted Date
2015-03-04
Lead Sponsor
Kyowa Kirin Co., Ltd.
Target Recruit Count
45
Registration Number
NCT01497145

Darbe Administration in Newborns Undergoing Cooling for Encephalopathy

Phase 1
Completed
Conditions
Hypoxic Ischemic Encephalopathy
Interventions
First Posted Date
2011-11-11
Last Posted Date
2024-07-23
Lead Sponsor
University of Utah
Target Recruit Count
30
Registration Number
NCT01471015
Locations
🇺🇸

University of New Mexico, Albuquerque, New Mexico, United States

🇺🇸

Intermountain Medical Center, Sandy, Utah, United States

🇺🇸

Vanderbilt University School of Medicine, Nashville, Tennessee, United States

and more 4 locations

Study to Evaluate Darbepoetin Alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease

Phase 1
Withdrawn
Conditions
Anemia
Chronic Kidney Disease
Interventions
First Posted Date
2011-09-02
Last Posted Date
2016-06-17
Lead Sponsor
Amgen
Registration Number
NCT01428154

To Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Erythropoietin

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2011-06-02
Last Posted Date
2012-07-19
Lead Sponsor
Green Cross Corporation
Target Recruit Count
100
Registration Number
NCT01363934

Darbepoetin Alfa in Patients With Anemic Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Phase 3
Completed
Conditions
MDS
Interventions
First Posted Date
2011-05-30
Last Posted Date
2017-12-19
Lead Sponsor
Amgen
Target Recruit Count
147
Registration Number
NCT01362140
Locations
🇨🇭

Research Site, Zurich, Switzerland

Lenalidomide and Darbepoetin in Low-Intermediate Risk Myelodysplastic Syndrome (MDS)

Phase 2
Terminated
Conditions
Leukemia
Interventions
First Posted Date
2010-10-18
Last Posted Date
2012-08-07
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
1
Registration Number
NCT01222195
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

Comparison Study of Standard Care Against Combination of Growth Factors Agents for Low-risk Myelodysplastic Syndromes

Phase 3
Completed
Conditions
Myelodysplastic Syndrome
Interventions
Procedure: Blood Red Cell Transfusion
First Posted Date
2010-09-08
Last Posted Date
2025-02-06
Lead Sponsor
Barts & The London NHS Trust
Target Recruit Count
360
Registration Number
NCT01196715
Locations
🇬🇧

Birmingham Cancer Research UK Clinical Trial Unit, Birmingham, United Kingdom

🇬🇧

St Bartholomew's Hospital, London, United Kingdom

🇬🇧

CECM Institute of Cancer, London, United Kingdom

and more 1 locations
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