NCT00004465

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

Terminated Phase 3 Last updated 1 June 2017

What this trial tests

Phase 3 trial testing SYNSORB Pk in Hemolytic Uremic Syndrome in 145 participants. Terminated before completion.

Timeline

27 July 1997

Primary endpoint
14 April 2001

14 April 2001

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	145
Start date	27 July 1997
Primary completion	14 April 2001
Estimated completion	14 April 2001
Sites	27 locations across Canada, United States

Drugs / interventions tested

• SYNSORB Pk — full drug profile →
• Placebo

Conditions studied

• Hemolytic Uremic Syndrome — all drugs for Hemolytic Uremic Syndrome →

Sponsor

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

Who can join

Adults 6 Months to 18, any sex, with Hemolytic Uremic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.