Darbepoetin alfa

Generic Name: Darbepoetin alfa

Brand Names: Aranesp

Drug Type: Biotech

Chemical Formula: -

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

Associated Therapies: -

Clinical Trials

Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa

Phase 3

Completed

Conditions: Anemia in Chronic Kidney Disease in Non-dialysis Patients

Interventions: Drug: Roxadustat
Drug: Darbepoetin alfa

First Posted Date: 2013-12-27

Last Posted Date: 2024-11-14

Lead Sponsor: Astellas Pharma Europe B.V.

Target Recruit Count: 616

Registration Number: NCT02021318

Locations: 🇧🇬
Site BG35927, Sofia, Bulgaria
🇫🇷
Site FR33004, Avignon, France
🇩🇪
Site DE49057, Hoyerswerda, Germany

and more 122 locations

A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference Drug

Phase 2

Completed

Conditions: Renal Anemia Associated With Chronic Renal Failure (CRF)

Interventions: Drug: roxadustat
Drug: darbepoetin alfa

First Posted Date: 2013-06-27

Last Posted Date: 2024-10-30

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 130

Registration Number: NCT01888445

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: Drug: Darbepoetin alfa

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
Drug: Darbepoetin alfa

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: Drug: Paricalcitol
Drug: Darbepoetin alfa

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

Darbe Administration in Newborns Undergoing Cooling for Encephalopathy

Phase 1

Completed

Conditions: Hypoxic Ischemic Encephalopathy

Interventions: Drug: Darbepoetin alfa
Drug: Placebo

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: Drug: Darbepoetin alfa

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: Drug: GC1113
Drug: Darbepoetin alfa

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: Drug: Placebo
Drug: Darbepoetin alfa

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: Drug: Lenalidomide
Drug: Darbepoetin alfa

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

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