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

This study has been completed.
Sponsor:
Collaborator:
Long Island Jewish Medical Center
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004465
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: October 2003
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 27 Study Locations
Sponsors and Collaborators
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 July 31, 2014