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

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

This study has been completed.

Study NCT00004465. Last updated on June 23, 2005. Information provided by Office of Rare Diseases (ORD)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Hemolytic Uremic Syndrome

Intervention ^†

Drug: SYNSORB Pk

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

204

Start Date ^†

July 1998

Completion Date

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)

Gender

Both

Ages

6 Months to 18 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Canada

Administrative Information Fields

NCT ID ^†

NCT00004465

Organization ID

199/13923

Secondary IDs ^††

LIJMC-96-5-186, LIJMC-R01DK52147

Study Sponsor ^†

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

Collaborators ^††

Long Island Jewish Medical Center

Investigators ^†

Study Chair:

Howard Trachtman

Long Island Jewish Medical Center

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

October 2003

First Received Date ^†

October 18, 1999

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.