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 β-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
-

Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2012-11-30
Last Posted Date
2014-04-21
Lead Sponsor
Amgen
Target Recruit Count
41
Registration Number
NCT01737879
Locations
🇺🇸

Research Site, Chesapeake, Virginia, United States

Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis

First Posted Date
2011-11-24
Last Posted Date
2016-09-20
Lead Sponsor
Takeda
Target Recruit Count
184
Registration Number
NCT01478971
Locations
🇺🇸

Research Facility, San Antonio, Texas, United States

Efficacy and Safety of Peginesatide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Participants Previously Treated With Epoetin.

Phase 2
Completed
Conditions
Interventions
First Posted Date
2008-09-15
Last Posted Date
2012-08-15
Lead Sponsor
Takeda
Target Recruit Count
59
Registration Number
NCT00752791

Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA

First Posted Date
2008-05-19
Last Posted Date
2012-06-29
Lead Sponsor
Affymax
Target Recruit Count
114
Registration Number
NCT00680043
Locations
🇷🇺

Research Facility, Volzhsk, Russian Federation

A Safety and Tolerability Study of Peginesatide in Anemic Cancer Patients Receiving Cytotoxic Chemotherapy.

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2008-03-06
Last Posted Date
2011-12-01
Lead Sponsor
Takeda
Target Recruit Count
2
Registration Number
NCT00629876

Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis

First Posted Date
2008-01-21
Last Posted Date
2013-02-12
Lead Sponsor
Affymax
Target Recruit Count
493
Registration Number
NCT00598442
Locations
🇬🇧

Research Facility, London, United Kingdom

Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis

First Posted Date
2008-01-21
Last Posted Date
2013-02-12
Lead Sponsor
Affymax
Target Recruit Count
490
Registration Number
NCT00598273
Locations
🇵🇷

Research Facility, San Juan, Puerto Rico

Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis

First Posted Date
2008-01-18
Last Posted Date
2013-03-08
Lead Sponsor
Affymax
Target Recruit Count
823
Registration Number
NCT00597584
Locations
🇬🇧

Research Facility, Swansea, United Kingdom

🇩🇪

Research Facilities (2), Bremen, Germany

Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis

First Posted Date
2008-01-18
Last Posted Date
2013-02-12
Lead Sponsor
Affymax
Target Recruit Count
803
Registration Number
NCT00597753
Locations
🇺🇸

Research Facilities (2), Norfolk, Virginia, United States

🇺🇸

Research Facility, Oshkosh, Wisconsin, United States

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