NCT00004465

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hemolytic Uremic Syndrome

Interventions

Type	Name	Description
DRUG	SYNSORB Pk
DRUG	Placebo

Timeline

• Start date: 1997-07-27
• Primary completion: 2001-04-14
• Completion: 2001-04-14
• First posted: 1999-10-19
• Last updated: 2017-06-01

Locations

27 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study