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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00004465
• Other study ID #: 199/13923
• Secondary ID: LIJMC-96-5-186R0
• Status: Terminated
• Phase: Phase 3
• First received: October 18, 1999
• Last updated: May 30, 2017
• Start date: July 27, 1997
• Est. completion date: April 14, 2001

Study information

• Verified date: May 2017
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 145
• Est. completion date: April 14, 2001
• Est. primary completion date: April 14, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• SYNSORB Pk

• Placebo

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Medical College of Georgia Hospital and Clinics	Augusta	Georgia
United States	Boston Floating Hospital Infants and Children	Boston	Massachusetts
United States	Maimonides Medical Center	Brooklyn	New York
United States	Children's Hospital of Buffalo	Buffalo	New York
United States	University of Virginia	Charlottesville	Virginia
United States	Ohio State University Children's Hospital	Columbus	Ohio
United States	Children's Hospital of Denver	Denver	Colorado
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	St. Barnabas Medical Center	Livingston	New Jersey
United States	University of Wisconsin Children's Hospital	Madison	Wisconsin
United States	North Shore University Hospital	Manhasset	New York
United States	West Virginia University Hospitals	Morgantown	West Virginia
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Weill Medical College of Cornell University	New York	New York
United States	Children's Hospital of the King's Daughters	Norfolk	Virginia
United States	Children's Hospital at St. Joseph's	Paterson	New Jersey
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York
United States	Jack D. Weiler Hospital of the Albert Einstein College of Medicine	The Bronx	New York
United States	New York Medical College	Valhalla	New York
United States	Alfred I. Dupont Institute	Wilmington	Delaware
United States	Bowman Gray School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Long Island Jewish Medical Center

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Trachtman H, Cnaan A, Christen E, Gibbs K, Zhao S, Acheson DW, Weiss R, Kaskel FJ, Spitzer A, Hirschman GH; Investigators of the HUS-SYNSORB Pk Multicenter Clinical Trial.. Effect of an oral Shiga toxin-binding agent on diarrhea-associated hemolytic uremi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to death or serious extrarenal events		60 days
Primary	Time to dialysis		60 days