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

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator:	Long Island Jewish Medical Center
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004465

Purpose

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.

Condition	Intervention	Phase
Hemolytic Uremic Syndrome	Drug: SYNSORB Pk	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

Resource links provided by NLM:

Drug Information available for: TAK 751S

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	204
Study Start Date:	July 1998

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

Ages Eligible for Study:	6 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004465

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Locations

United States, Colorado
Children's Hospital of Denver
Denver, Colorado, United States, 80218
United States, Delaware
Alfred I. Dupont Institute
Wilmington, Delaware, United States, 19899
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Medical College of Georgia Hospital and Clinics
Augusta, Georgia, United States, 30912-3620
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5265
United States, Massachusetts
Boston Floating Hospital Infants and Children
Boston, Massachusetts, United States, 02111
United States, New Jersey
Children's Hospital at St. Joseph's
Patterson, New Jersey, United States, 07503
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, New York
Children's Hospital of Buffalo
Buffalo, New York, United States, 14222
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Jack D. Weiler Hospital of the Albert Einstein College of Medicine
Bronx, New York, United States, 10461
New York Medical College
Valhalla, New York, United States, 10595
North Shore University Hospital
Manhasset, New York, United States, 11030
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-7775
University of Rochester Medical Center
Rochester, New York, United States, 14642
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, North Carolina
Bowman Gray School of Medicine
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Ohio State University Children's Hospital
Columbus, Ohio, United States, 43205-2696
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, West Virginia
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9162
United States, Wisconsin
University of Wisconsin Children's Hospital
Madison, Wisconsin, United States, 53792-4108
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2R7

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Long Island Jewish Medical Center

Investigators

Study Chair:

Howard Trachtman

Long Island Jewish Medical Center

More Information

No publications provided

Study ID Numbers:	199/13923, LIJMC-96-5-186, LIJMC-R01DK52147
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004465 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

E. coli infection
bacterial infection
hemolytic uremic syndrome

immunologic disorders and infectious disorders
rare disease
renal and genitourinary disorders

Additional relevant MeSH terms:

Azotemia
Disease
Hematologic Diseases
Blood Platelet Disorders
Anemia
Anemia, Hemolytic
Hemolytic-Uremic Syndrome

Thrombocytopenia
Pathologic Processes
Urologic Diseases
Syndrome
Uremia
Kidney Diseases

ClinicalTrials.gov processed this record on November 27, 2009