Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-04 @ 8:54 AM
Study NCT ID:
NCT00113958
Status:
COMPLETED
Last Update Posted:
2013-05-13
First Post:
2005-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cinacalcet Study to Reach Kidney Disease Outcomes Quality Initiative (K/DOQI) Levels
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
Cinacalcet Open Label Study to Reach K/DOQI Levels
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to observe the effects of a treatment strategy that incorporates cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) to K/DOQI recommended targets in subjects with end stage renal disease (ESRD) receiving hemodialysis, on bio-intact parathyroid hormone, corrected serum calcium, serum phosphorus, and calcium phosphorus product.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: