Peginesatide

Generic Name
Peginesatide
Brand Names
-
Drug Type
Biotech
Chemical Formula
-
CAS Number
913976-27-9
Unique Ingredient Identifier
JX56W9N61Q
Background

Peginesatide is a synthetic peptide attached to polyethylene glycol for the treatment of anemia. The polyethylene glycol moiety helps make the drug less immunogenic and prolongs its plasma half-life. Chemically, peginesatide is designed to mimic the pharmacological activity of erythropoietin, but is not a replica of the structure itself. Peginesatide consists of two 21-amino acid chains that are covalently bonded by a linker derived from iminodiacetic acid and Ξ²-alanine. FDA approved March 27, 2012.

Indication

Peginesatide is used for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis

Associated Conditions
-
Associated Therapies
-

Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD (EU)

First Posted Date
2007-03-29
Last Posted Date
2012-06-29
Lead Sponsor
Affymax
Target Recruit Count
114
Registration Number
NCT00453973
Locations
πŸ‡¬πŸ‡§

Research Facility, Swansea, United Kingdom

Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis

First Posted Date
2007-02-13
Last Posted Date
2012-06-29
Lead Sponsor
Affymax
Target Recruit Count
91
Registration Number
NCT00434330
Locations
πŸ‡¬πŸ‡§

Research Facility, London, United Kingdom

Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD

First Posted Date
2006-09-07
Last Posted Date
2012-06-29
Lead Sponsor
Affymax
Target Recruit Count
81
Registration Number
NCT00372489
Locations
πŸ‡ΊπŸ‡Έ

Research Facility, San Antonio, Texas, United States

Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease

First Posted Date
2006-04-17
Last Posted Date
2019-03-14
Lead Sponsor
Takeda
Target Recruit Count
22
Registration Number
NCT00314795
Locations
πŸ‡¬πŸ‡§

Research Facility, London, United Kingdom

Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

Phase 2
Completed
Conditions
Interventions
First Posted Date
2006-01-09
Last Posted Date
2012-12-21
Lead Sponsor
Affymax
Target Recruit Count
60
Registration Number
NCT00272662
Locations
πŸ‡¬πŸ‡§

Research Facilities, London, United Kingdom

πŸ‡΅πŸ‡±

Research Facility, Szczecin, Poland

Peginesatide for Anemia in Chronic Hemodialysis Patients

First Posted Date
2005-09-29
Last Posted Date
2012-12-21
Lead Sponsor
Affymax
Target Recruit Count
165
Registration Number
NCT00228449
Locations
πŸ‡ΊπŸ‡Έ

Research Facility, Norfolk, Virginia, United States

Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients

First Posted Date
2005-09-29
Last Posted Date
2012-12-21
Lead Sponsor
Affymax
Target Recruit Count
139
Registration Number
NCT00228436
Locations
πŸ‡¬πŸ‡§

Research Facility, Swansea, United Kingdom

πŸ‡¬πŸ‡§

Research Facilities, London, United Kingdom

Safety of Single Doses of Peginesatide in Patients With Chronic Kidney Disease

First Posted Date
2005-04-27
Last Posted Date
2012-12-21
Lead Sponsor
Affymax
Target Recruit Count
17
Registration Number
NCT00109291
Locations
πŸ‡¬πŸ‡§

Research Facility, London, United Kingdom

Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers

First Posted Date
2004-12-01
Last Posted Date
2012-12-21
Lead Sponsor
Affymax
Target Recruit Count
28
Registration Number
NCT00097747
Locations
πŸ‡¬πŸ‡§

Research Facility, London, United Kingdom

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