Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228436
Status:
COMPLETED
Last Update Posted:
2012-12-21
First Post:
2005-09-27
Brief Title:
Safety PD PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients
Sponsor:
Affymax
Organization:
Affymax
Study Overview
Official Title:
A Phase 2 Open-label Multi-center Sequential Dose Finding Study of the Safety Pharmacodynamics and Pharmacokinetics of Multiple Doses of Subcutaneously Administered Peginesatide in Chronic Kidney Disease Patients Not on Dialysis and Not on Erythropoiesis Stimulating Agent ESA Treatment
Status:
COMPLETED
Status Verified Date:
2012-12
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 evaluate the safety pharmacodynamics PD and pharmacokinetics PK of multiple subcutaneous injections of peginesatide in participants with chronic kidney disease CKD not on dialysis who had not received erythropoiesis stimulating agent ESA treatment
Detailed Description:
This was a Phase 2 dose finding study designed to evaluate peginesatide treatment of participants with CKD not on ESA treatment The objective was to determine the range of doses of peginesatide administered subcutaneously once every 4 weeks Q4W that increased and maintained hemoglobin at 11 to 13 gdL
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 |
|---|---|---|---|
| 2005-002218-39 | EUDRACT_NUMBER | None | None |