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 III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)

Phase 3
Completed
Conditions
Anemia
Interventions
First Posted Date
2016-09-23
Last Posted Date
2019-04-02
Lead Sponsor
Kissei Pharmaceutical Co., Ltd.
Registration Number
NCT02912494

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

Phase 3
Completed
Conditions
Dialysis-Dependent Chronic Kidney Disease
Anemia
Interventions
First Posted Date
2016-09-08
Last Posted Date
2022-06-28
Lead Sponsor
Akebia Therapeutics
Target Recruit Count
3554
Registration Number
NCT02892149
Locations
🇺🇸

AMPM Research Clinic, Miami, Florida, United States

🇬🇧

Research Site, Doncaster, South Yorkshire, United Kingdom

🇺🇦

Research Site #1, Cherkassy, Ukraine

and more 3 locations

Erythropoietin for Management of Anemia Caused by Chemotherapy

Phase 2
Completed
Conditions
Diffuse Large B-cell Lymphoma
Interventions
First Posted Date
2016-09-07
Last Posted Date
2020-02-20
Lead Sponsor
Kosin University Gospel Hospital
Target Recruit Count
53
Registration Number
NCT02890602

Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)

Phase 3
Completed
Conditions
Anaemia
Interventions
First Posted Date
2016-08-24
Last Posted Date
2024-04-02
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
3872
Registration Number
NCT02876835
Locations
🇻🇳

GSK Investigational Site, Ho Chi Minh, Vietnam

Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)

Phase 3
Completed
Conditions
Dialysis-Dependent Chronic Kidney Disease
Anemia
Interventions
First Posted Date
2016-08-15
Last Posted Date
2022-07-18
Lead Sponsor
Akebia Therapeutics
Target Recruit Count
369
Registration Number
NCT02865850
Locations
🇺🇦

Research Site, Zhytomyr, Ukraine

🇺🇸

Research Site #1, Chattanooga, Tennessee, United States

🇷🇺

Research Site #2, Kemerovo, Russian Federation

Cost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients

Phase 4
Completed
Conditions
Anemia
Chronic Kidney Disease
Interventions
First Posted Date
2016-06-29
Last Posted Date
2019-09-10
Lead Sponsor
Andrea L Woodland
Target Recruit Count
50
Registration Number
NCT02817555

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

Phase 3
Completed
Conditions
Non-Dialysis-Dependent Chronic Kidney Disease
Anemia
Interventions
First Posted Date
2016-02-11
Last Posted Date
2022-06-27
Lead Sponsor
Akebia Therapeutics
Target Recruit Count
1725
Registration Number
NCT02680574
Locations
🇷🇸

Research Site #3, Belgrade, Serbia

🇿🇦

Research Site #1, Durban, KwaZulu-Natal, South Africa

🇿🇦

Research Site #2, Durban, KwaZulu-Natal, South Africa

and more 1 locations

Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease

Phase 3
Completed
Conditions
Anemia
Non-Dialysis-Dependent Chronic Kidney Disease
Interventions
First Posted Date
2016-01-07
Last Posted Date
2022-06-27
Lead Sponsor
Akebia Therapeutics
Target Recruit Count
1751
Registration Number
NCT02648347
Locations
🇬🇧

Research Site, Swansea, United Kingdom

🇿🇦

Research Site #1, Durban, KwaZulu-Natal, South Africa

🇿🇦

Research Site #2, Durban, KwaZulu-Natal, South Africa

and more 1 locations

Pharmacokinetics and Pharmacodynamics Study of BCD-066 Compared to Aranesp® in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2015-07-23
Last Posted Date
2016-06-14
Lead Sponsor
Biocad
Target Recruit Count
74
Registration Number
NCT02506881
Locations
🇷🇺

City Mariin Hospital, St. Petersburg, Russian Federation

Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients

Phase 3
Completed
Conditions
Anemia
Chronic Kidney Disease
End Stage Renal Failure on Dialysis
Interventions
First Posted Date
2015-07-23
Last Posted Date
2020-05-07
Lead Sponsor
Biocad
Target Recruit Count
196
Registration Number
NCT02506868
Locations
🇷🇺

NEFROS Ltd, Medical Centre, Krasnodar, Russian Federation

🇷🇺

N.I.Pirogov City Clinical Hospital #1, Moscow, Russian Federation

🇷🇺

Alyans Biomedical - Ural'skaya gruppa, Izhevsk, Russian Federation

and more 27 locations
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