A Phase 3 interventional study of SYNSORB Pk and Placebo in Hemolytic Uremic Syndrome, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Terminated at 27 sites in 2 countries. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2017-06-01.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
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.
28 studies on the registry are indexed under Hemolytic-Uremic Syndrome; 7 are open to participants now.
This study's enrollment of 145 is above the median of 60 across 13 interventional studies indexed under Hemolytic-Uremic Syndrome.
Browse Hemolytic-Uremic Syndrome studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 538 studies on the registry; 55 are open to participants now.
Of its 80 completed or terminated interventional studies of FDA-regulated products, 51 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Patient Characteristics--
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral Shiga toxin-binding agent (500 mg/kg/day)
Drug: SYNSORB Pk
Cornmeal placebo
Drug: Placebo
Also known as: Oral Shiga Toxin Binding Agent
Time to death or serious extrarenal events
Time frame: 60 days
Time to dialysis
Time frame: 60 days
Plan to share: No
Ran from Jul 1997 to primary completion in Apr 2001, 44 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) →