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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004465

Enrollment

145

Registered

1999-10-19

Start date

1997-07-27

Completion date

2001-04-14

Last updated

2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemolytic Uremic Syndrome

Keywords

E. coli infection, bacterial infection, hemolytic uremic syndrome, immunologic disorders and infectious disorders, rare disease, renal and genitourinary disorders

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.

Interventions

DRUGSYNSORB Pk

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 18 Years

Healthy volunteers

Inclusion 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)

Design outcomes

Primary

Measure	Time frame
Time to death or serious extrarenal events	60 days
Time to dialysis	60 days

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026