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

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

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.

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.

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)