Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated Hemolytic Uremic Syndrome
NCT ID: NCT00004465
Last Updated: 2017-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
145 participants
INTERVENTIONAL
1997-07-27
2001-04-14
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SYNSORB Pk
Oral Shiga toxin-binding agent (500 mg/kg/day)
SYNSORB Pk
Placebo
Cornmeal placebo
Placebo
Interventions
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SYNSORB Pk
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
--Disease Characteristics--
* Clinically diagnosed E. coli-associated diarrhea-associated hemolytic uremic syndrome (HUS)
* Diarrheal prodrome within 7 days before onset of disease
* No HUS associated with the following: Hereditary Post-bone marrow transplantation Streptococcus pneumoniae infection
* No prior catastrophic complications
--Patient Characteristics--
* Hematopoietic: Thrombocytopenia less than 140,000/mm3 Fragmented red blood cells
* Renal: Renal involvement (hematuria, proteinuria, or azotemia) No underlying glomerular disease
* Other: HIV negative No pre-existing structural abnormality or dysmotility syndrome of the gastrointestinal tract No inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
6 Months
18 Years
ALL
No
Sponsors
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Long Island Jewish Medical Center
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Howard Trachtman
Role: STUDY_CHAIR
Long Island Jewish Medical Center
Locations
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Children's Hospital of Denver
Denver, Colorado, United States
Alfred I. Dupont Institute
Wilmington, Delaware, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Medical College of Georgia Hospital and Clinics
Augusta, Georgia, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Boston Floating Hospital Infants and Children
Boston, Massachusetts, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Children's Hospital at St. Joseph's
Paterson, New Jersey, United States
Maimonides Medical Center
Brooklyn, New York, United States
Children's Hospital of Buffalo
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
Jack D. Weiler Hospital of the Albert Einstein College of Medicine
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Bowman Gray School of Medicine
Winston-Salem, North Carolina, United States
Ohio State University Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, 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 Wisconsin Children's Hospital
Madison, Wisconsin, United States
University of Alberta
Edmonton, Alberta, Canada
Countries
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References
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Trachtman H, Cnaan A, Christen E, Gibbs K, Zhao S, Acheson DW, Weiss R, Kaskel FJ, Spitzer A, Hirschman GH; Investigators of the HUS-SYNSORB Pk Multicenter Clinical Trial. Effect of an oral Shiga toxin-binding agent on diarrhea-associated hemolytic uremic syndrome in children: a randomized controlled trial. JAMA. 2003 Sep 10;290(10):1337-44. doi: 10.1001/jama.290.10.1337.
Imdad A, Nelson JR, Tanner-Smith EE, Huang D, Gomez-Duarte OG. Interventions for preventing diarrhoea-associated haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2025 Apr 25;4(4):CD012997. doi: 10.1002/14651858.CD012997.pub3.
Imdad A, Mackoff SP, Urciuoli DM, Syed T, Tanner-Smith EE, Huang D, Gomez-Duarte OG. Interventions for preventing diarrhoea-associated haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Jul 5;7(7):CD012997. doi: 10.1002/14651858.CD012997.pub2.
Other Identifiers
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LIJMC-96-5-186
Identifier Type: OTHER
Identifier Source: secondary_id
199/13923
Identifier Type: -
Identifier Source: org_study_id
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