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

Hemolytic Uremic Syndrome Clinical Trial

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

Status Terminated

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Azotemia
• Hemolysis
• Hemolytic Uremic Syndrome
• Hemolytic-Uremic Syndrome
• Syndrome

• NCT number: NCT00004465
• Study type: Interventional
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Status: Terminated
• Phase: Phase 3
• Start date: July 27, 1997
• Completion date: April 14, 2001