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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 is a Phase 4 study that has completed, run by Fresenius Medical Care North America. The registered enrollment target is 38 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01427907
The ClinicalTrials.gov registry entry for NCT01427907 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fresenius Medical Care North America, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sevelamer carbonate is the first listed.
NCT01427907 reports 0 study locations.
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.
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