Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated Hemolytic Uremic Syndrome
- Registration Number
- NCT00004465
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 145
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Cornmeal placebo SYNSORB Pk SYNSORB Pk Oral Shiga toxin-binding agent (500 mg/kg/day)
- Primary Outcome Measures
Name Time Method Time to dialysis 60 days Time to death or serious extrarenal events 60 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Ohio State University Children's Hospital
🇺🇸Columbus, Ohio, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Boston Floating Hospital Infants and Children
🇺🇸Boston, Massachusetts, United States
New York Medical College
🇺🇸Valhalla, New York, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Children's Hospital of Buffalo
🇺🇸Buffalo, New York, United States
St. Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Jack D. Weiler Hospital of the Albert Einstein College of Medicine
🇺🇸The Bronx, New York, United States
University of Wisconsin Children's Hospital
🇺🇸Madison, Wisconsin, United States
Alfred I. Dupont Institute
🇺🇸Wilmington, Delaware, United States
Medical College of Georgia Hospital and Clinics
🇺🇸Augusta, Georgia, United States
Children's Hospital at St. Joseph's
🇺🇸Paterson, New Jersey, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Children's Hospital of the King's Daughters
🇺🇸Norfolk, Virginia, United States
West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Children's Hospital of Denver
🇺🇸Denver, Colorado, United States
Bowman Gray School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States