Full Text View
Tabular View
No Study Results Posted
Related Studies
Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated Hemolytic Uremic Syndrome
This study has been completed.
Study NCT00004465   Information provided by Office of Rare Diseases (ORD)
First Received: October 18, 1999   Last Updated: June 23, 2005   History of Changes

October 18, 1999
June 23, 2005
July 1998
 
 
 
Complete list of historical versions of study NCT00004465 on ClinicalTrials.gov Archive Site
 
 
 
Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated Hemolytic Uremic Syndrome
 

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.

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.

Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control
Hemolytic Uremic Syndrome
Drug: SYNSORB Pk
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
204
 
 

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)
Both
6 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00004465
 
199/13923, LIJMC-96-5-186, LIJMC-R01DK52147
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Long Island Jewish Medical Center
Study Chair: Howard Trachtman Long Island Jewish Medical Center
Office of Rare Diseases (ORD)
October 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP