Clinical trial NCT00004465: Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated Hemolytic Uremic Syndrome
Official title: Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hemolytic Uremic Syndrome
Keywords: E. coli infection
bacterial infection
hemolytic uremic syndrome
immunologic disorders and infectious disorders
rare disease
renal and genitourinary disorders
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: Long Island Jewish Medical Center
First posted: 1999-10-19
Enrollment: 145
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Time to death or serious extrarenal events
timeFrame: 60 days
measure: Time to dialysis
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Children's Hospital of Denver
state: Colorado
city: Wilmington
country: United States
facility: Alfred I. Dupont Institute
state: Delaware
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia Hospital and Clinics
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Boston
country: United States
facility: Boston Floating Hospital Infants and Children
state: Massachusetts
city: Livingston
country: United States
facility: St. Barnabas Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: Paterson
country: United States
facility: Children's Hospital at St. Joseph's
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Buffalo
country: United States
facility: Children's Hospital of Buffalo
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: State University of New York Health Sciences Center - Stony Brook
state: New York
city: The Bronx
country: United States
facility: Jack D. Weiler Hospital of the Albert Einstein College of Medicine
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Winston-Salem
country: United States
facility: Bowman Gray School of Medicine
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospitals
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Children's Hospital
state: Wisconsin
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: Long Island Jewish Medical Center
name: Howard Trachtman
role: STUDY_CHAIR
References:
citation: 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 uremic syndrome in children: a randomized controlled trial. JAMA. 2003 Sep 10;290(10):1337-44. doi: 10.1001/jama.290.10.1337.
citation: Imdad A, Mackoff SP, Urciuoli DM, Syed T, Tanner-Smith EE, Huang D, Gomez-Duarte OG. Interventions for preventing diarrhoea-associated haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Jul 5;7(7):CD012997. doi: 10.1002/14651858.CD012997.pub2.