Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345839
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2006-06-27
Brief Title:
EVOLVE Trial EValuation Of Cinacalcet Hydrochloride HCl Therapy to Lower CardioVascular Events
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
EValuation Of Cinacalcet Hydrochloride HCl Therapy to Lower CardioVascular Events
Status:
COMPLETED
Status Verified Date:
2022-11
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:
EVOLVE
Brief Summary:
The purpose of this study is to evaluate the effects of cinacalcet cinacalcet HCl or SensiparMimpara on cardiovascular events and death in chronic kidney disease CKD patients with secondary hyperparathyroidism HPT who are receiving dialysis
Detailed Description:
Secondary HPT is common in people with CKD Patients with secondary HPT often have high parathyroid hormone PTH levels and may develop large parathyroid glands in the neck Patients with secondary HPT may have bone disease osteodystrophy This bone disease may cause bone pain fractures and poor formation of red blood cells Other problems from secondary HPT may include increases in blood levels of calcium and phosphorus These may cause calcium to deposit in body tissues Calcium deposits can cause arthritis joint pain and swelling muscle inflammation itching gangrene death of soft tissue or heart and lung problems New evidence suggests that secondary HPT is associated with cardiovascular disease and increased death risk The purpose of this study is to evaluate the effects of cinacalcet cinacalcet HCl or SensiparMimpara on cardiovascular events having to do with the heart and its blood vessels and death in chronic kidney disease CKD patients with secondary hyperparathyroidism HPT who are receiving dialysis These events include death from any reason heart attack and episodes where the heart does not get enough oxygen peripheral vascular disease narrowing of vessels that carry blood to the legs arms stomach or kidneys and heart failure a condition that occurs when the heart is unable to pump enough blood to meet the needs of the bodys tissues
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