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

Desidustat in the Treatment of Anemia in CKD

Phase 3
Completed
Conditions
Chronic Kidney Disease Stage 3
Anemia
Chronic Kidney Disease Stage 4
Chronic Kidney Disease Stage 5
Interventions
First Posted Date
2019-07-09
Last Posted Date
2021-11-24
Lead Sponsor
Zydus Lifesciences Limited
Target Recruit Count
588
Registration Number
NCT04012957
Locations
🇮🇳

Sawai Man Singh (SMS) Medical College and Hospital, Jaipur, Rajasthan, India

🇮🇳

Max Super Specialty Hospital, New Delhi, Delhi, India

🇮🇳

Eternal Hospital, Jaipur, Rajasthan, India

and more 27 locations

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease

Phase 1
Completed
Conditions
Anemia Associated With Chronic Kidney Disease
Interventions
First Posted Date
2019-06-19
Last Posted Date
2020-09-16
Lead Sponsor
Akebia Therapeutics
Target Recruit Count
46
Registration Number
NCT03992066
Locations
🇺🇸

Research Site, Chattanooga, Tennessee, United States

Mechanisms of EPO-induced Hypertension

Phase 2
Active, not recruiting
Conditions
Chronic Kidney Disease
Blood Pressure
Anemia
Interventions
First Posted Date
2019-01-22
Last Posted Date
2025-02-26
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
27
Registration Number
NCT03810911
Locations
🇺🇸

Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis, Indiana, United States

A Novel Erythropoiesis Stimulating Protein (NESP; Darbopoetin Alfa) for the Treatment of Anemia in Lung Cancer Patients Receiving Multi-cycle Platinum-Containing Chemotherapy

Phase 3
Completed
Conditions
Anemia
Interventions
First Posted Date
2018-12-14
Last Posted Date
2018-12-20
Lead Sponsor
Amgen
Target Recruit Count
320
Registration Number
NCT03776032

Maintenance Treatment of Renal Anemia in Dialysis Subjects

Phase 3
Completed
Conditions
Renal Insufficiency, Chronic
Anemia
Interventions
Drug: Placebo of Molidustat (BAY85-3934)
Drug: Placebo of Darbepoetin alfa
First Posted Date
2018-06-01
Last Posted Date
2021-01-29
Lead Sponsor
Bayer
Target Recruit Count
229
Registration Number
NCT03543657
Locations
🇯🇵

Chibune Clinic, Osaka, Japan

🇯🇵

Maruko Central Hospital, Ueda, Nagano, Japan

🇯🇵

Houshikai Kano hospital, Kasuya-gun, Fukuoka, Japan

and more 50 locations

Pharmacokinetics Study of CJ-40001 and NESP® After Single Dose Administration in Health Male Volunteers

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
Drug: CJ-40001 60ug
First Posted Date
2018-05-31
Last Posted Date
2018-05-31
Lead Sponsor
HK inno.N Corporation
Target Recruit Count
56
Registration Number
NCT03542916
Locations
🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)

First Posted Date
2018-02-27
Last Posted Date
2024-03-27
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
6
Registration Number
NCT03446612
Locations
🇬🇧

GSK Investigational Site, London, United Kingdom

Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan

Phase 3
Completed
Conditions
Anemia; Hemodialysis Dependent Chronic Kidney Disease
Interventions
First Posted Date
2018-02-20
Last Posted Date
2023-12-28
Lead Sponsor
Mitsubishi Tanabe Pharma Corporation
Target Recruit Count
323
Registration Number
NCT03439137
Locations
🇯🇵

Research site, Yamagata, Japan

A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects

Phase 3
Completed
Conditions
Anemia
Renal Insufficiency, Chronic
Interventions
First Posted Date
2017-11-22
Last Posted Date
2021-01-29
Lead Sponsor
Bayer
Target Recruit Count
164
Registration Number
NCT03350347
Locations
🇯🇵

Matsunami Health Promotion Clinic, Hashima-gun, Gifu, Japan

🇯🇵

Mazda Hospital of Mazda Motor Corporation, Aki-gun, Hiroshima, Japan

🇯🇵

Higashihiroshima Medical Center, Higashihiroshima, Hiroshima, Japan

and more 56 locations

A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects

Phase 3
Completed
Conditions
Anemia
Renal Insufficiency, Chronic
Interventions
First Posted Date
2017-11-22
Last Posted Date
2021-01-29
Lead Sponsor
Bayer
Target Recruit Count
162
Registration Number
NCT03350321
Locations
🇯🇵

Steel Memorial Yawata Hospital, Kitakyushu, Fukuoka, Japan

🇯🇵

St.Mary's Hospital, Kurume, Fukuoka, Japan

🇯🇵

Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan

and more 58 locations
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