Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004465
Status:
TERMINATED
Last Update Posted:
2017-06-01
First Post:
1999-10-18
Brief Title:
Phase III Randomized Study of SYNSORB Pk in Children With E Coli-Associated Hemolytic Uremic Syndrome
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Phase III Randomized Study of SYNSORB Pk in Children With E Coli-Associated
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy at review by DSMB using pre-specified monitoring criteria
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Determine the effect of SYNSORB Pk therapy on mortality and frequency of severe extrarenal complications observed in children with acute stage E coli-associated hemolytic uremic syndrome
II Determine the effect of SYNSORB Pk therapy on the need for the duration of dialysis in these patients
III Determine the effect of SYNSORB Pk therapy on the recovery of renal function and resolution of urinary abnormalities in these patients
II Determine the effect of SYNSORB Pk therapy on the need for the duration of dialysis in these patients
III Determine the effect of SYNSORB Pk therapy on the recovery of renal function and resolution of urinary abnormalities in these patients
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are randomized to receive either SYNSORB Pk or placebo
Patients receive oral SYNSORB Pk or placebo three times daily for 7 days Patients are followed on days 7 14 28 and 60 after discharge from the hospital
Patients receive oral SYNSORB Pk or placebo three times daily for 7 days Patients are followed on days 7 14 28 and 60 after discharge from the hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK052147 | NIH | Long Island Jewish Medical Center | httpsreporternihgovquickSearchR01DK052147 |
| LIJMC-96-5-186 | OTHER | None | None |