Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated Hemolytic Uremic Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated

Conditions
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Hemolytic Uremic Syndrome

Intervention / Treatment
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* Drug: SYNSORB Pk
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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PROTOCOL ENTRY 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)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYNSORB Pk<br>Oral Shiga toxin-binding agent (500 mg/kg/day) | Drug: SYNSORB Pk<br> <br> * Other names: Oral Shiga Toxin Binding Agent;|
| Placebo Comparator: Placebo<br>Cornmeal placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to death or serious extrarenal events |  | 60 days | 
| Time to dialysis |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rare disease, E. coli infection, bacterial infection, hemolytic uremic syndrome, immunologic disorders and infectious disorders, renal and genitourinary disorders