Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511186
Status:
TERMINATED
Last Update Posted:
2012-04-02
First Post:
2007-08-02
Brief Title:
A Study in Sepsis Patients With Renal Failure
Sponsor:
AM-Pharma
Organization:
AM-Pharma
Study Overview
Official Title:
A Phase-IIa Double-blind Randomized Placebo-controlled Study on the Safety and Early Efficacy of Alkaline Phosphatase in Sepsis Patients With Renal Failure
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sufficient POC to switch development from bovine AP to recombinant AP
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 study is to investigate the safety and tolerability of AP in sepsis patients with renal failure and to investigate the effect of AP on inflammatory and clinical parameters in sepsis patients with renal failure
Detailed Description:
RATIONALE FOR THE STUDY
A previous clinical study conducted in centers in The Netherlands and Belgium have shown a substantial clinical benefit of AP treatment in patients with sepsis and associated acute renal failure see Introduction above The latter results require confirmation in a prospective study as the current subject of this Protocol
Choice of Drugs
The proposed study medication AP is identical to the study medication used in the previous clinical study in sepsis patients with single or multiple end-organ failure Since there is no current proven treatment for these patients the controls as in previous studies is placebo
Choice of patient population
The aim is to enroll a maximum of 26 patients positive for sepsis with an APACHE score of 20 and 28 determined within 24 hours of entry and who will be analyzed on an intention to treat ITT basis
A previous clinical study conducted in centers in The Netherlands and Belgium have shown a substantial clinical benefit of AP treatment in patients with sepsis and associated acute renal failure see Introduction above The latter results require confirmation in a prospective study as the current subject of this Protocol
Choice of Drugs
The proposed study medication AP is identical to the study medication used in the previous clinical study in sepsis patients with single or multiple end-organ failure Since there is no current proven treatment for these patients the controls as in previous studies is placebo
Choice of patient population
The aim is to enroll a maximum of 26 patients positive for sepsis with an APACHE score of 20 and 28 determined within 24 hours of entry and who will be analyzed on an intention to treat ITT basis
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