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

This study has been terminated.
(Lack of efficacy at review by DSMB using pre-specified monitoring criteria)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004465
First Posted: October 19, 1999
Last Update Posted: June 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Long Island Jewish Medical Center
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  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 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Time to death or serious extrarenal events [ Time Frame: 60 days ]
  • Time to dialysis [ Time Frame: 60 days ]

Enrollment: 145
Actual Study Start Date: July 27, 1997
Study Completion Date: April 14, 2001
Primary Completion Date: April 14, 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYNSORB Pk
Oral Shiga toxin-binding agent (500 mg/kg/day)
Drug: SYNSORB Pk
Other Name: Oral Shiga Toxin Binding Agent
Placebo Comparator: Placebo
Cornmeal placebo
Drug: Placebo

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00004465     History of Changes
Other Study ID Numbers: 199/13923
LIJMC-96-5-186 ( Other Identifier: Long Island Jewish Medical Center )
R01DK052147 ( U.S. NIH Grant/Contract )
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
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
Syndrome
Hemolysis
Azotemia
Disease
Pathologic Processes
Uremia
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic
Anemia
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Shiga Toxins
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action