Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated Hemolytic Uremic Syndrome
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated|
- Time to death or serious extrarenal events [ Time Frame: 60 days ]
- Time to dialysis [ Time Frame: 60 days ]
|Actual Study Start Date:||July 27, 1997|
|Study Completion Date:||April 14, 2001|
|Primary Completion Date:||April 14, 2001 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004465
Show 27 Study Locations
|Study Chair:||Howard Trachtman||Long Island Jewish Medical Center|