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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 is a Phase 1 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 12 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00458289
The ClinicalTrials.gov registry entry for NCT00458289 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lanthanum carbonate (chewed vs. crushed) is the first listed.
NCT00458289 reports 0 study locations.
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.
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