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NCT00324376 · ClinicalTrials.gov registry record · Phase 2
Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
A Phase 2 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00324376: Completed Phase 2 study, sponsored by Genzyme, a Sanofi Company.
NCT00324376 is a Phase 2 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00324376, a Phase 2 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to one of the following treatment sequences: 1. sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals 2. sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal. Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening.
Interventions
- DRUG Sevelamer hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2003-03 |
| Est. Completion | 2004-05 |
| Phase | Phase 2 |
What the finished NCT00324376 record still lists
NCT00324376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Sevelamer hydrochloride is the first listed.
NCT00324376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00324376 about?
NCT00324376 is a clinical study titled "Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing". A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two wee...
What is the current status of trial NCT00324376?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2003-03. Estimated completion is 2004-05.
What interventions are being tested in trial NCT00324376?
The interventions under investigation include: Sevelamer hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00324376?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00324376's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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