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NCT00004465 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Terminated
Registry status
Phase 3
Development phase
145
Enrollment target

NCT00004465: Clinical Trial Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT00004465 is a Phase 3 study that was terminated before completion, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 145 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00004465, a Phase 3 study, was terminated before completion, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

TERMINATED
Registry status
Phase 3
Development phase
145 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG SYNSORB Pk

Trial Details

FieldValue
Enrollment Target 145 participants
Start Date 1997-07-27
Est. Completion 2001-04-14
Phase Phase 3

Why NCT00004465 stopped before completion

NCT00004465 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00004465 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00004465 about?

NCT00004465 is a clinical study titled "Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated Hemolytic Uremic Syndrome". 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 thes...

What is the current status of trial NCT00004465?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 1997-07-27. Estimated completion is 2001-04-14.

What interventions are being tested in trial NCT00004465?

The interventions under investigation include: Placebo (DRUG), SYNSORB Pk (DRUG).

Who is sponsoring clinical trial NCT00004465?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00004465's enrollment target sits among peer trials

145 1555th of 2000 higher than 442 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00004465, the US trial registry maintained by the National Library of Medicine. NCT00004465 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.