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NCT01427907 · ClinicalTrials.gov registry record · Phase 4
Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
A Phase 4 study, sponsored by Fresenius Medical Care North America.
- Completed
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
NCT01427907: Completed Phase 4 study, sponsored by Fresenius Medical Care North America.
NCT01427907 is a Phase 4 study that has completed, run by Fresenius Medical Care North America. The registered enrollment target is 38 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01427907, a Phase 4 study, has completed, sponsored by Fresenius Medical Care North America.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and sevelamer carbonate in maintaining serum phosphorus levels This is a phase IV, multicenter, randomized, open-label, cross-over study to assess the equivalence of a liquid formulation of a calcium-based phosphate binder, COS, to sevelamer carbonate tablets, in hemodialysis dependent Chronic Kidney Disease subjects (CKD). The aim of the study is to maintain serum phosphorus level and establish equivalence between COS and sevelamer carbonate tablets.
Primary Outcome
The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject
Interventions
- DRUG Sevelamer carbonate
- DRUG Calcium acetate oral solution (COS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-07 |
| Phase | Phase 4 |
What the finished NCT01427907 record still lists
NCT01427907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Sevelamer carbonate is the first listed.
NCT01427907 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01427907 about?
NCT01427907 is a clinical study titled "Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients". The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and sevelamer carbonate in maintaining serum phosphorus levels This is a phase IV, multicenter, randomized, open-label, cross-over study to assess the equivalence of a liquid formulation of a calcium-based phos...
What is the current status of trial NCT01427907?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2011-09. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01427907?
The interventions under investigation include: Sevelamer carbonate (DRUG), Calcium acetate oral solution (COS) (DRUG).
Who is sponsoring clinical trial NCT01427907?
This trial is sponsored by Fresenius Medical Care North America, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01427907's enrollment target sits among peer trials
38 1476th of 2000 higher than 519 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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