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Phase III Randomized Study of SYNSORB Pk in Children with E. coli-Associated Hemolytic Uremic Syndrome Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Phase III Randomized Study of SYNSORB Pk in Children with E. coli-Associated Hemolytic Uremic Syndrome conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase III Randomized Study of SYNSORB Pk in Children with E. coli-Associated Hemolytic Uremic Syndrome Clinical research trials and Phase III Randomized Study of SYNSORB Pk in Children with E. coli-Associated Hemolytic Uremic Syndrome health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like 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 Hemolytic Uremic Syndrome Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Phase III Randomized Study of SYNSORB Pk in Children with E. coli-Associated Hemolytic Uremic Syndrome clinical trial. Subjects frequently get the best healthcare possible for their Phase III Randomized Study of SYNSORB Pk in Children with E. coli-Associated Hemolytic Uremic Syndrome condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.

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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 Hemolytic Uremic Syndrome

For Condition: Hemolytic Uremic Syndrome
Status: Completed
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , Long Island Jewish Medical Center
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 6 Months/18 Years
Genders: Both
Protocol Entry 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)
Total Enrollment: 204

Location and Contact Information:

Overall Study Official:
HowardTrachtman,  Study Chair,  Long Island Jewish Medical Center

Maimonides Medical Center
Brooklyn,  New York,  11219
United States
 

Medical College of Georgia Hospital and Clinics
Augusta,  Georgia,  30912-3620
United States
 

Indiana University Cancer Center
Indianapolis,  Indiana,  46202-5265
United States
 

Children's Hospital of Buffalo
Buffalo,  New York,  14222
United States
 

University of Virginia
Charlottesville,  Virginia,  22908
United States
 

Children's Hospital of Denver
Denver,  Colorado,  80218
United States
 

University of Wisconsin Children's Hospital
Madison,  Wisconsin,  53792-4108
United States
 

St. Barnabas Medical Center
Livingston,  New Jersey,  07039
United States
 

State University of New York Health Sciences Center - Stony Brook
Stony Brook,  New York,  11790-7775
United States
 

Children's Hospital at St. Joseph's
Paterson,  New Jersey,  07503
United States
 

West Virginia University Hospitals
Morgantown,  West Virginia,  26506-9162
United States
 

Long Island Jewish Medical Center
New Hyde Park,  New York,  11040
United States
 

New York Medical College
Valhalla,  New York,  10595
United States
 

Alfred I. Dupont Institute
Wilmington,  Delaware,  19899
United States
 

University of Rochester Medical Center
Rochester,  New York,  14642
United States
 

University of Alberta
Edmonton,  Alberta,  T6G 2R7
Canada
 

Jack D. Weiler Hospital of the Albert Einstein College of Medicine
Bronx,  New York,  10461
United States
 

North Shore University Hospital
Manhasset,  New York,  11030
United States
 

Bowman Gray School of Medicine
Winston Salem,  North Carolina,  27157
United States
 

Robert Wood Johnson Medical School
New Brunswick,  New Jersey,  08903
United States
 

Children's Hospital of Philadelphia
Philadelphia,  Pennsylvania,  19104
United States
 

Boston Floating Hospital Infants and Children
Boston,  Massachusetts,  02111
United States
 

Children's Hospital of the King's Daughters
Norfolk,  Virginia,  23507
United States
 

Weill Medical College of Cornell University
New York City,  New York,  10021
United States
 

Children's Hospital of Pittsburgh
Pittsburgh,  Pennsylvania,  15213
United States
 

Ohio State University Children's Hospital
Columbus,  Ohio,  43205-2696
United States
 

Emory University School of Medicine
Atlanta,  Georgia,  30322
United States
 


Additional Information:
Study ID Numbers:
  199/13923;  LIJMC-96-5-186,LIJMC-R01DK52147
Study Start Date: July 1998
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004465

Other Hemolytic Uremic Syndrome Studies:
1. Phase III Randomized Study of SYNSORB Pk in Children with E. coli-Associated Hemolytic Uremic Syndrome

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