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

Phase 3

Terminated

• Conditions: Hemolytic Uremic Syndrome
• Interventions: Drug: Placebo; Drug: SYNSORB Pk

• Registration Number: NCT00004465
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief 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.

Study Timeline

• Study Start: 1997-07-27
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Primary Completion: 2001-04-14
• Study Completion: 2001-04-14
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-30
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Cornmeal placebo
SYNSORB Pk	SYNSORB Pk	Oral Shiga toxin-binding agent (500 mg/kg/day)

Primary Outcome Measures

Name	Time	Method
Time to dialysis	60 days
Time to death or serious extrarenal events	60 days

Trial Locations

Locations (27)

Children's Hospital of Denver; 🇺🇸 Denver, Colorado, United States

Alfred I. Dupont Institute; 🇺🇸 Wilmington, Delaware, United States

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Medical College of Georgia Hospital and Clinics; 🇺🇸 Augusta, Georgia, United States

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Boston Floating Hospital Infants and Children; 🇺🇸 Boston, Massachusetts, United States

St. Barnabas Medical Center; 🇺🇸 Livingston, New Jersey, United States

Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States

Children's Hospital at St. Joseph's; 🇺🇸 Paterson, New Jersey, United States

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States

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