Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211978
Status:
COMPLETED
Last Update Posted:
2008-01-08
First Post:
2005-09-13
Brief Title:
EPICEffect of PhosLo on Phosphorus Levels in Chronic Kidney Disease
Sponsor:
Nabi Biopharmaceuticals
Organization:
Nabi Biopharmaceuticals
Study Overview
Official Title:
EPIC Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease A Prospective Multicenter Randomized Double-Blinded Placebo-Controlled Parallel Arm Study of PhosLo on Phosphorus Levels in Subjects With Chronic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2007-12
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 is to determine if calcium acetate PhosLo can control serum phosphorus in pre-dialysis patients with moderate to severe impairment of kidney function
Detailed Description:
In patients with impaired kidney function dietary phosphorus can not be completely excreted which leads to elevated levels of serum phosphorus Elevated serum phosphorus leads to increased levels of parathyroid hormone PTH and is associated with bone disease and other adverse consequences such as soft-tissue and vascular calcification and increased morbidity and mortality It is therefore important to prevent hyperphosphatemia and maintain serum phosphorus levels within the range recommended by KDOQI In patients on dialysis phosphate binders are routinely used to control serum phosphorus by absorbing dietary phosphate during the transit through the intestine However the use of phosphate binders for non-dialyzed patients with chronic kidney disease CKD is not an FDA approved indication although some physicians treat patients prior to dialysis based on clinical judgment The goal of this study is to demonstrate the efficacy of calcium acetate PhosLo in controlling serum phosphorus in patients with moderate to severe decrease in kidney function
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 |
|---|---|---|---|
| EUDRACT 2005-002565-36 | None | None | None |