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 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.
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)