Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109291
Status:
TERMINATED
Last Update Posted:
2012-12-21
First Post:
2005-04-27
Brief Title:
Safety of Single Doses of Peginesatide in Patients With Chronic Kidney Disease
Sponsor:
Affymax
Organization:
Affymax
Study Overview
Official Title:
A Phase 2a Randomized Double-blind Placebo-controlled Sequential Dose Escalation Study of the Safety Pharmacodynamics and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Patients With Chronic Kidney Disease Who Are Not on Dialysis and Who Have Not Had Prior Erythropoiesis Stimulating Agent ESA Treatment
Status:
TERMINATED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety profile of single intravenous IV dose levels of peginesatide in participants with chronic kidney diseaseCKD not on dialysis
Detailed Description:
This was a Phase 2a randomized double-blind placebo-controlled sequential dose escalation study conducted at a single clinical center The study was designed to evaluate up to 6 treatment cohorts of 9 participants with CKD not on dialysis in the first cohort and 5 participants in each subsequent cohort In each treatment cohort participants were randomly assigned to receive either a single dose of peginesatide n7 in the first cohort n4 in subsequent cohorts or placebo n2 in the first cohort n1 in subsequent cohorts Participants were followed for a minimum of 28 days
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 |
|---|---|---|---|
| 2005-000125-35 | EUDRACT_NUMBER | None | None |