Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211939
Status:
COMPLETED
Last Update Posted:
2008-01-08
First Post:
2005-09-13
Brief Title:
CARE-2 Calcium Acetate PhosLoSevelamerRenagel Evaluation Study 2 for Heart Calcification in Dialysis Patients
Sponsor:
Nabi Biopharmaceuticals
Organization:
Nabi Biopharmaceuticals
Study Overview
Official Title:
CARE-2 Calcium Acetate PhosLoSevelamerRenagel Evaluation Study 2
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 the study is to evaluate the effects of two phosphate binders PhosLo and sevelamer on heart calcification in dialysis patients The study will use a non-invasive technique electron beam computed tomography CT scanning to measure calcium in the coronary arteries the aortic valve and the mitral valve
Detailed Description:
Cardiovascular disease is the major cause of death and disability in patients with end-stage renal disease on hemodialysis It has been hypothesized that ingestion of calcium-based phosphate binders results in net positive calcium balance and vascular calcium deposition Chertow et al tested the role of ingested calcium in the progression of cardiovascular calcification in the Treat-To-Goal study Kidney International 62245 2002 They reported that patients treated with calcium-based phosphate binders demonstrated progressive cardiovascular calcification while patients treated with a calcium-free binder sevelamer showed stabilization or improvement in calcification scores However the protocol did not prohibit intake of supplemental oral calcium in the sevelamer group which confounded their ability to accurately test the calcium hypothesis Moreover due to the cholesterol sequestering activities of sevelamer the low-density lipoprotein LDL cholesterol was lower among sevelamer-treated patients than the calcium treated patients resulting in a major imbalance in a cardiovascular risk factor Lowering LDL level reduces progression of CVC and therefore confounds interpretation of the study Subsequently it has been reported in the lay press that patients randomized to sevelamer or calcium-based binders in the Dialysis Clinical Outcomes Revisited DCOR study have failed to show a difference in mortality or major secondary endpoints Suki et al To be presented American Society of Nephrology November 2005 To circumvent these limitations the CARE-2 study will test the hypothesis that if LDL levels are lowered to a similar level in calcium acetate and sevelamer-treated patients there will be no difference in the progression of cardiac calcification CARE-2 will randomize patients with elevated LDL to calcium acetate or sevelamer Atorvastatin is added to achieve LDL 70 mgdL in both treatment groups The primary endpoint is change in cardiac calcification scores determined by electron beam scanning after 1 year Secondary endpoints include the ability of calcium acetate and sevelamer to control phosphorus and meet NKF-KDOQI guidelines
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