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NCT00458289 · ClinicalTrials.gov registry record · Phase 1

Efficacy of Phosphate Binding in Healthy Volunteers: Chewed Versus Crushed Lanthanum Carbonate

A Phase 1 study, sponsored by University of Illinois at Chicago.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT00458289: Completed Phase 1 study, sponsored by University of Illinois at Chicago.

NCT00458289 is a Phase 1 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00458289, a Phase 1 study, has completed, sponsored by University of Illinois at Chicago.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

Patients with end-stage renal disease (ESRD) commonly have high concentrations of phosphorous, a mineral, in the blood (hyperphosphatemia). This is a result of their inability to excrete phosphorous by the kidneys. This in turn may result in the development of a condition known as secondary hyperparathyroidism and renal osteodystrophy or bone disease. As such, these patients often receive medications known as phosphate binders such as calcium carbonate or acetate, sevelamer, aluminum hydroxide and lanthanum carbonate to manage and treat hyperphosphatemia. Lanthanum carbonate is a newly available phosphate binding agent that is effective in the management of hyperphosphatemia and preventing secondary hyperparathyroidism. It works in the gastrointestinal tract by binding to the phosphorus in the diet. ESRD patients taking lanthanum carbonate are counseled to chew the tablets completely before swallowing, with or immediately after meals. However, patients who are intubated or receiving nutrition via feeding tubes are unable to chew the tablets. For these patients, medications are commonly crushed and administered via the tube. Moreover, some patients prefer to crush the tablets and mix it with food instead of chewing. To date, it is not known if crushing the lanthanum carbonate tablets prior to administration and taking it with food would be as effective as chewing them. The purpose of this study is to compare the efficacy of phosphate binding between chewed and crushed lanthanum carbonate tablets.

Interventions

  • DRUG Lanthanum carbonate (chewed vs. crushed)

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2007-01
Est. Completion 2008-08
Phase Phase 1
University of Illinois at Chicago

430 total trials

What the finished NCT00458289 record still lists

NCT00458289 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 1 intervention - of which Lanthanum carbonate (chewed vs. crushed) is the first listed.

NCT00458289 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00458289 about?

NCT00458289 is a clinical study titled "Efficacy of Phosphate Binding in Healthy Volunteers: Chewed Versus Crushed Lanthanum Carbonate". Patients with end-stage renal disease (ESRD) commonly have high concentrations of phosphorous, a mineral, in the blood (hyperphosphatemia). This is a result of their inability to excrete phosphorous by the kidneys. This in turn may result in the development of a condition known as secondary hyperpar...

What is the current status of trial NCT00458289?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2007-01. Estimated completion is 2008-08.

What interventions are being tested in trial NCT00458289?

The interventions under investigation include: Lanthanum carbonate (chewed vs. crushed) (DRUG).

Who is sponsoring clinical trial NCT00458289?

This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00458289's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00458289, the US trial registry maintained by the National Library of Medicine. NCT00458289 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.