Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500682
Status:
COMPLETED
Last Update Posted:
2022-06-07
First Post:
2007-07-11
Brief Title:
A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease EPPIC-1
Sponsor:
Mitsubishi Tanabe Pharma Corporation
Organization:
Mitsubishi Tanabe Pharma Corporation
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients With Moderate to Severe Chronic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2022-05
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:
1 To evaluate the effectiveness of AST-120 spherical carbon adsorbent added to standard-of-care therapy in moderate to severe Chronic Kidney Disease CKD on time to first occurrence of any event of the triple composite outcome of initiation of dialysis kidney transplant or doubling of serum creatinine sCr when compared with placebo 2 To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD 3 To evaluate the effects of AST-120 versus placebo on other measures of renal function
Detailed Description:
None
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