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 Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

Phase 3
Recruiting
Conditions
Anemia of Chronic Kidney Disease
Interventions
First Posted Date
2024-06-20
Last Posted Date
2024-06-24
Lead Sponsor
Genexine, Inc.
Target Recruit Count
429
Registration Number
NCT06466785
Locations
🇬🇪

Batumi Dialysis and Nephrology Center, Batumi, Georgia

🇬🇪

L.Managadze National Center of Urology, Tbilisi, Georgia

🇬🇪

Tbilisi Heart And Vascular Clinic, Tbilisi, Georgia

and more 6 locations

Pharmacokinetics Comparison Study of JT1801 and NESP® After Single Dose Administration in Chinese Health Male Volunteers

Phase 4
Completed
Conditions
Renal Anemia
Interventions
Drug: JT1801 60ug
First Posted Date
2023-05-18
Last Posted Date
2023-11-22
Lead Sponsor
Yi Fang
Target Recruit Count
74
Registration Number
NCT05864261
Locations
🇨🇳

Peking University People's Hospital, Beijing, Beijing, China

High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

Phase 3
Recruiting
Conditions
Anemia
Interventions
First Posted Date
2023-03-15
Last Posted Date
2023-03-15
Lead Sponsor
Hallym University Medical Center
Target Recruit Count
312
Registration Number
NCT05768997
Locations
🇰🇷

Hallym University Medical Center, Anyang-si, Korea, Republic of

Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants

Phase 2
Recruiting
Conditions
Iron-deficiency
Prematurity
Iron Malabsorption
Iron Deficiency Anemia
Interventions
Drug: Oral iron supplements
Drug: Low Molecular Weight Iron Dextran
First Posted Date
2022-04-22
Last Posted Date
2024-12-06
Lead Sponsor
University of Washington
Target Recruit Count
120
Registration Number
NCT05340465
Locations
🇺🇸

University of Washington, Seattle, Washington, United States

A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis

Phase 2
Completed
Conditions
Renal Anemia
Interventions
Drug: AND017 capsules TIW
Drug: AND017 capsules QW
First Posted Date
2022-03-03
Last Posted Date
2024-06-28
Lead Sponsor
Kind Pharmaceuticals LLC
Target Recruit Count
175
Registration Number
NCT05265325
Locations
🇺🇸

North America Research Institute, Riverside, California, United States

🇺🇸

US Renal Care - Pine Bluff, Pine Bluff, Arkansas, United States

🇨🇳

The Affiliated Zhongshan Hospital of Dalian University, Dalian, Liaoning, China

and more 22 locations

Comparison of Darbepoetin Alpha and Recombinant Human Erythropoietin for Treatment of Anemia in Children With Chronic Kidney Disease

Phase 4
Completed
Conditions
Anemia of Chronic Kidney Disease
Interventions
First Posted Date
2021-07-13
Last Posted Date
2021-07-13
Lead Sponsor
Rufaida Mazahir
Target Recruit Count
50
Registration Number
NCT04959578
Locations
🇮🇳

Sir Ganga Ram Hospital, New Delhi, Delhi, India

Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA

Phase 1
Active, not recruiting
Conditions
Myelodysplastic Syndromes
Interventions
First Posted Date
2021-03-15
Last Posted Date
2025-04-10
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
13
Registration Number
NCT04798339
Locations
🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

🇺🇸

Emory-Winship Cancer Institute, Atlanta, Georgia, United States

Darbepoetin in Neonatal Encephalopathy Trial

Phase 2
Recruiting
Conditions
Neonatal Encephalopathy
Interventions
First Posted Date
2020-06-16
Last Posted Date
2024-03-19
Lead Sponsor
Imperial College London
Target Recruit Count
150
Registration Number
NCT04432662
Locations
🇬🇧

Birmingham Womens Hospital, Birmingham, United Kingdom

🇬🇧

Imperial College Healthcare Trust, London, United Kingdom

🇬🇧

Bradford Teaching Hospitals NHS Foundation Trust, Bradford, United Kingdom

and more 6 locations

Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)

Phase 3
Completed
Conditions
Anemia
Interventions
First Posted Date
2020-03-18
Last Posted Date
2022-11-21
Lead Sponsor
Akebia Therapeutics
Target Recruit Count
319
Registration Number
NCT04313153
Locations
🇪🇸

Research Site, Valencia, Spain

🇪🇸

Research Site #2, Barcelona, Spain

A Study to Evaluate Efficacy and Safety of JTZ-951 Compared to Darbepoetin Alfa in Korean Renal Anemia Patients Receiving Hemodialysis.

Phase 3
Completed
Conditions
Anemia of Chronic Kidney Disease
Interventions
First Posted Date
2019-07-22
Last Posted Date
2021-03-22
Lead Sponsor
JW Pharmaceutical
Target Recruit Count
172
Registration Number
NCT04027517
Locations
🇰🇷

SMG-SNU Boramae Medical Center, Seoul, Korea, Republic of

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