Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434330
Status:
COMPLETED
Last Update Posted:
2012-06-29
First Post:
2007-02-12
Brief Title:
Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis
Sponsor:
Affymax
Organization:
Affymax
Study Overview
Official Title:
A Phase 2 Open-Label Multi-Center Dose Finding Study of the Safety Pharmacodynamics and Pharmacokinetics of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 determine the dose ranges of peginesatide administered intravenously or subcutaneously that maintained hemoglobin in participants on dialysis whose hemoglobin values were stable on epoetin alfa or beta
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
Six dose cohorts of 15 participants each were evaluated in this study Participants received peginesatide injection once every 4 weeks administered intravenously or subcutaneously for a total of 7 doses
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
Six dose cohorts of 15 participants each were evaluated in this study Participants received peginesatide injection once every 4 weeks administered intravenously or subcutaneously for a total of 7 doses
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-002815-28 | EUDRACT_NUMBER | None | None |