Ignite Creation Date:
2024-05-05 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00785629
Status:
COMPLETED
Last Update Posted:
2012-10-30
First Post:
2008-11-04
Brief Title:
A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD
Sponsor:
Denver Nephrologists PC
Organization:
Denver Nephrologists PC
Study Overview
Official Title:
A Double Blind Randomized Placebo Controlled Trial of Maintenance of Normal Serum Phosphorus in Chronic Kidney Disease CKD
Status:
COMPLETED
Status Verified Date:
2012-09
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 the ability of 3 commercially available phosphorus binders calcium acetate sevelamer carbonate and lanthanum carbonate to achieve and maintain a phosphorus level in the normal range in patients with chronic kidney disease
Detailed Description:
It is the specific aim of this pilot study to assess the feasibility of achieving and maintaining a serum P less than or equal to 35 mgdL 113 mmolL in patients with eGFR 20 and 45 mLmin with any of the 3 commercially available P lowering agents calcium acetate sevelamer carbonate or lanthanum carbonate Results of this study will clarify the degree of separation in serum P that can be achieved with the use of P lowering agents and the current standard of care P binder initiation when P 55 mgdL or 178 mmolL Furthermore this knowledge combined with analyses of the secondary aims and outcomes of interest will serve to facilitate the design of a properly powered randomized placebo controlled clinical outcomes trial that will firmly establish the necessity of achieving a specific target P in patients with CKD The secondary aims of this pilot study are to provide insight into the optimal detection of progression of abnormalities in mineral metabolism and their relationship to vascular disease in CKD The tertiary aim is to evaluate long term outcomes related to phosphorus normalization with respect to renal replacement therapy or death
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