Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132431
Status:
COMPLETED
Last Update Posted:
2009-02-13
First Post:
2005-08-19
Brief Title:
START Sensipar Treatment Algorithm to Reach KDOQI Targets in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
Sensipar Treatment Algorithm to Reach KDOQI Targets in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism
Status:
COMPLETED
Status Verified Date:
2009-02
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 research is to study the effects and safety of Sensipar approved by the Food and Drug Administration FDA in patients with kidney failure who are being treated with dialysis and have uncontrolled secondary hyperparathyroidism HPT
Detailed Description:
The purposes of this study are - To assess the effectiveness of a treatment algorithm that includes Sensipar on bio-intact parathyroid hormone biPTH adjusted serum calcium Ca serum phosphorus P and calcium-phosphorus product Ca x P levels in the management of SHPT in CKD subjects on dialysis by determining achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative KDOQI Guideline targets - To assess the use of vitamin D sterols and phosphate binders when Sensipar is incorporated in the treatment of SHPT - To assess the safety and tolerability of Sensipar
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