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

Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

Phase 3
Completed
Conditions
Anemia; Non-dialysis Dependent Chronic Kidney Disease
Interventions
First Posted Date
2017-11-01
Last Posted Date
2023-12-28
Lead Sponsor
Mitsubishi Tanabe Pharma Corporation
Target Recruit Count
304
Registration Number
NCT03329196
Locations
🇯🇵

Research site, Yamanashi, Japan

Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Phase 3
Withdrawn
Conditions
Anemia
Dialysis-Dependent Chronic Kidney Disease
Interventions
First Posted Date
2017-08-08
Last Posted Date
2018-11-05
Lead Sponsor
Akebia Therapeutics
Registration Number
NCT03242967
Locations
🇺🇸

Research Site, Northridge, California, United States

Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration

Phase 2
Recruiting
Conditions
Perinatal Stroke
PAIS
Neonatal Stroke
Interventions
First Posted Date
2017-05-31
Last Posted Date
2023-12-07
Lead Sponsor
UMC Utrecht
Target Recruit Count
80
Registration Number
NCT03171818
Locations
🇳🇱

Wilhelmina Childrens Hostpital/University Medical Center Utrecht, Utrecht, Netherlands

Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants

Phase 3
Active, not recruiting
Conditions
Neurocognitive
Neonatal
Neuroprotective
Neurodevelopmental Impairment
Interventions
Drug: Placebo
First Posted Date
2017-05-30
Last Posted Date
2024-10-30
Lead Sponsor
NICHD Neonatal Research Network
Target Recruit Count
650
Registration Number
NCT03169881
Locations
🇺🇸

Stanford University, Palo Alto, California, United States

🇺🇸

Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States

🇺🇸

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States

and more 13 locations

EPO-4-Rhesus Study

Phase 2
Conditions
Erythroblastosis, Fetal
Erythroblastosis Fetalis, Rh Disease
Erythroblastosis Fetalis Due to RH Antibodies
Erythroblastosis Fetalis Due to Isoimmunization
Interventions
First Posted Date
2017-04-07
Last Posted Date
2019-10-02
Lead Sponsor
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Target Recruit Count
42
Registration Number
NCT03104426
Locations
🇳🇱

Leiden University Medical Center, Leiden, Netherlands

Mild Encephalopathy in the Newborn Treated With Darbepoetin

Phase 2
Completed
Conditions
Neonatal Encephalopathy
Hypoxic-Ischemic Encephalopathy Mild
Interventions
Drug: Normal Saline
First Posted Date
2017-03-07
Last Posted Date
2023-12-21
Lead Sponsor
University of New Mexico
Target Recruit Count
28
Registration Number
NCT03071861
Locations
🇺🇸

University of Utah, Salt Lake City, Utah, United States

Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)

Phase 3
Completed
Conditions
Anaemia
Interventions
First Posted Date
2017-01-24
Last Posted Date
2021-10-20
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
312
Registration Number
NCT03029208
Locations
🇬🇧

GSK Investigational Site, Middlesbrough, United Kingdom

Evaluating the Effect of Standard-of-care Erythropoiesis-stimulating Agents on Forearm Blood Flow in Nondialysis-dependent Subjects With Anaemia Associated With Chronic Kidney Disease.

Completed
Conditions
Chronic Kidney Disease
Cardiovascular Diseases
Interventions
First Posted Date
2016-12-09
Last Posted Date
2024-02-07
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust
Target Recruit Count
29
Registration Number
NCT02987465
Locations
🇬🇧

Addenbrooke's Hospital, Cambridge, Cambridgeshire, United Kingdom

A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia

Phase 3
Completed
Conditions
Hemodialysis Chronic Kidney Disease Patients With Anemia
Interventions
First Posted Date
2016-11-02
Last Posted Date
2024-10-30
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
303
Registration Number
NCT02952092
Locations
🇯🇵

Site JP00033, Aichi, Japan

🇯🇵

Site JP00004, Ehime, Japan

🇯🇵

Site JP00041, Ibaraki, Japan

and more 54 locations
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