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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.

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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

FieldValue
Enrollment Target 38 participants
Start Date 2011-09
Est. Completion 2012-07
Phase Phase 4

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.