Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated Hemolytic Uremic Syndrome
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|ClinicalTrials.gov Identifier: NCT00004465|
Recruitment Status : Terminated (Lack of efficacy at review by DSMB using pre-specified monitoring criteria)
First Posted : October 19, 1999
Last Update Posted : June 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemolytic Uremic Syndrome||Drug: SYNSORB Pk Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||145 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated|
|Actual Study Start Date :||July 27, 1997|
|Primary Completion Date :||April 14, 2001|
|Study Completion Date :||April 14, 2001|
Experimental: SYNSORB Pk
Oral Shiga toxin-binding agent (500 mg/kg/day)
Drug: SYNSORB Pk
Other Name: Oral Shiga Toxin Binding Agent
Placebo Comparator: Placebo
- Time to death or serious extrarenal events [ Time Frame: 60 days ]
- Time to dialysis [ Time Frame: 60 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004465
Show 27 Study Locations
|Study Chair:||Howard Trachtman||Long Island Jewish Medical Center|