Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372489
Status:
TERMINATED
Last Update Posted:
2012-06-29
First Post:
2006-09-05
Brief Title:
Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD
Sponsor:
Affymax
Organization:
Affymax
Study Overview
Official Title:
An Open-Label Multi-Center Extension Study to Evaluate the Safety and Tolerability of Peginesatide for the Long-Term Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to more robust long-term data generated in other active-controlled studies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to evaluate the long term safety and tolerability of peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease CKD who had received at least 24 weeks of peginesatide treatment in an earlier study
Detailed Description:
Anemia associated with chronic kidney disease is due to several factors primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin Ancillary factors include the shortened lifespan of red blood cells iron and other nutritional deficiencies infection and inflammation The presence and severity of anemia are related to the duration and extent of kidney failure Anemia is associated with increased mortality increased likelihood of hospitalization reduced cognitive function and increased left ventricular hypertrophy and heart failure
Erythropoiesis stimulating agents have been established as a treatment for anemia in subjects with chronic kidney disease and have improved the management of anemia over alternatives such as transfusion Peginesatide is a parenteral formulation developed for the treatment of anemia associated with chronic kidney disease Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents ESAs
Study participants had received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study NCT00228449 and were to receive doses of peginesatide for approximately 54 months However the Sponsor ended the study early
Erythropoiesis stimulating agents have been established as a treatment for anemia in subjects with chronic kidney disease and have improved the management of anemia over alternatives such as transfusion Peginesatide is a parenteral formulation developed for the treatment of anemia associated with chronic kidney disease Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents ESAs
Study participants had received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study NCT00228449 and were to receive doses of peginesatide for approximately 54 months However the Sponsor ended the study early
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None