search
Back to results

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

Primary Purpose

Hemolytic Uremic Syndrome

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SYNSORB Pk
Placebo
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemolytic Uremic Syndrome focused on measuring E. coli infection, bacterial infection, hemolytic uremic syndrome, immunologic disorders and infectious disorders, rare disease, renal and genitourinary disorders

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Children's Hospital of Denver
  • Alfred I. Dupont Institute
  • Emory University School of Medicine
  • Medical College of Georgia Hospital and Clinics
  • Indiana University Cancer Center
  • Boston Floating Hospital Infants and Children
  • St. Barnabas Medical Center
  • Robert Wood Johnson Medical School
  • Children's Hospital at St. Joseph's
  • Maimonides Medical Center
  • Children's Hospital of Buffalo
  • North Shore University Hospital
  • Long Island Jewish Medical Center
  • Weill Medical College of Cornell University
  • University of Rochester Medical Center
  • State University of New York Health Sciences Center - Stony Brook
  • Jack D. Weiler Hospital of the Albert Einstein College of Medicine
  • New York Medical College
  • Bowman Gray School of Medicine
  • Ohio State University Children's Hospital
  • Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh
  • University of Virginia
  • Children's Hospital of the King's Daughters
  • West Virginia University Hospitals
  • University of Wisconsin Children's Hospital
  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SYNSORB Pk

Placebo

Arm Description

Oral Shiga toxin-binding agent (500 mg/kg/day)

Cornmeal placebo

Outcomes

Primary Outcome Measures

Time to death or serious extrarenal events
Time to dialysis

Secondary Outcome Measures

Full Information

First Posted
October 18, 1999
Last Updated
May 30, 2017
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Long Island Jewish Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00004465
Brief Title
Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated Hemolytic Uremic Syndrome
Official Title
Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy at review by DSMB using pre-specified monitoring criteria
Study Start Date
July 27, 1997 (Actual)
Primary Completion Date
April 14, 2001 (Actual)
Study Completion Date
April 14, 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Long Island Jewish Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemolytic Uremic Syndrome
Keywords
E. coli infection, bacterial infection, hemolytic uremic syndrome, immunologic disorders and infectious disorders, rare disease, renal and genitourinary disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SYNSORB Pk
Arm Type
Experimental
Arm Description
Oral Shiga toxin-binding agent (500 mg/kg/day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Cornmeal placebo
Intervention Type
Drug
Intervention Name(s)
SYNSORB Pk
Other Intervention Name(s)
Oral Shiga Toxin Binding Agent
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Time to death or serious extrarenal events
Time Frame
60 days
Title
Time to dialysis
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Trachtman
Organizational Affiliation
Long Island Jewish Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Alfred I. Dupont Institute
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Medical College of Georgia Hospital and Clinics
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-3620
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5265
Country
United States
Facility Name
Boston Floating Hospital Infants and Children
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
St. Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Children's Hospital at St. Joseph's
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Children's Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
State University of New York Health Sciences Center - Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790-7775
Country
United States
Facility Name
Jack D. Weiler Hospital of the Albert Einstein College of Medicine
City
The Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Bowman Gray School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Ohio State University Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-9162
Country
United States
Facility Name
University of Wisconsin Children's Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-4108
Country
United States
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12966125
Citation
Trachtman H, Cnaan A, Christen E, Gibbs K, Zhao S, Acheson DW, Weiss R, Kaskel FJ, Spitzer A, Hirschman GH; Investigators of the HUS-SYNSORB Pk Multicenter Clinical Trial. Effect of an oral Shiga toxin-binding agent on diarrhea-associated hemolytic uremic syndrome in children: a randomized controlled trial. JAMA. 2003 Sep 10;290(10):1337-44. doi: 10.1001/jama.290.10.1337.
Results Reference
result
PubMed Identifier
34219224
Citation
Imdad A, Mackoff SP, Urciuoli DM, Syed T, Tanner-Smith EE, Huang D, Gomez-Duarte OG. Interventions for preventing diarrhoea-associated haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Jul 5;7(7):CD012997. doi: 10.1002/14651858.CD012997.pub2.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs