Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT00616902
Status:
TERMINATED
Last Update Posted:
2012-01-20
First Post:
2008-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5
Sponsor:
Abbott
Organization:
Study Overview
Official Title:
Clinical Study Protocol M10-221 The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5
Status:
TERMINATED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was prematurely terminated due to low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIMO II
Brief Summary:
To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-005092-33 | EUDRACT_NUMBER | None | View |