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NCT01057108 · ClinicalTrials.gov registry record · Phase 1
Double Blind Randomized Placebo Controlled Trial of FOSTRAP Chewing Gum in Patients With CKD and Hyperphosphatemia
A Phase 1 study, sponsored by Denver Nephrologists, P.C..
- Completed
- Registry status
- Phase 1
- Development phase
- 121
- Enrollment target
NCT01057108: Completed Phase 1 study, sponsored by Denver Nephrologists, P.C..
NCT01057108 is a Phase 1 study that has completed, run by Denver Nephrologists, P.C.. The registered enrollment target is 121 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (102% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01057108, a Phase 1 study, has completed, sponsored by Denver Nephrologists, P.C..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 121 participants
- Enrollment target
Study Summary
The phosphorus content in saliva is increased in chronic kidney disease. We hypothesize that a chewing gum that binds salivary phosphorus would be a novel, effective agent to reduce serum levels of phosphorus in patients with chronic kidney disease. We are testing this hypothesis using a chewing gum called FOSTRAP which has been shown to be effective in a small, non-randomized study in patients with chronic kidney disease on hemodialysis.
Interventions
- OTHER Placebo chewing gum
- OTHER FOSTRAP Chewing Gum
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2010-01 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
What the finished NCT01057108 record still lists
NCT01057108 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (102% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo chewing gum is the first listed.
NCT01057108 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01057108 about?
NCT01057108 is a clinical study titled "Double Blind Randomized Placebo Controlled Trial of FOSTRAP Chewing Gum in Patients With CKD and Hyperphosphatemia". The phosphorus content in saliva is increased in chronic kidney disease. We hypothesize that a chewing gum that binds salivary phosphorus would be a novel, effective agent to reduce serum levels of phosphorus in patients with chronic kidney disease. We are testing this hypothesis using a chewing gum...
What is the current status of trial NCT01057108?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 121 participants. The study started on 2010-01. Estimated completion is 2010-09.
What interventions are being tested in trial NCT01057108?
The interventions under investigation include: Placebo chewing gum (OTHER), FOSTRAP Chewing Gum (OTHER).
Who is sponsoring clinical trial NCT01057108?
This trial is sponsored by Denver Nephrologists, P.C., which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01057108's enrollment target sits among peer trials
121 476th of 2000 higher than 1,522 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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