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

This study has been completed.

First Received on October 18, 1999. Last Updated on June 23, 2005 History of Changes

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:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: atypical hemolytic-uremic syndrome MYH9-related disorder

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

Show 27 Study Locations

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

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

Hemolytic-Uremic Syndrome
Azotemia
Hemolysis
Uremia
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic

Anemia
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012