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

National Institutes of Health (NIH)

Status and phase

Terminated

Phase 3

Conditions

Hemolytic Uremic Syndrome

Treatments

Drug: SYNSORB Pk

Drug: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00004465

R01DK052147 (U.S. NIH Grant/Contract)

199/13923

LIJMC-96-5-186 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

145 patients

Sex

All

Ages

6 months to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)