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NCT01003223 · ClinicalTrials.gov registry record · NA

Phosphate Kinetic Modeling

A NA study of End Stage Renal Disease and Hyperphosphatemia, sponsored by Fresenius Medical Care North America.

Completed
Registry status
NA
Development phase
190
Enrollment target
1
Study location

NCT01003223 is a NA study of End Stage Renal Disease and Hyperphosphatemia that has completed, run by Fresenius Medical Care North America. The registered enrollment target is 190 participants, below the 831-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01003223, a NA study of End Stage Renal Disease and Hyperphosphatemia, has completed, sponsored by Fresenius Medical Care North America.

COMPLETED
Registry status
NA
Development phase
190 participants
Enrollment target
1
Study location

Study Summary

Cardiovascular disease is a major cause of death in hemodialysis (HD) patients and is associated with widespread vascular calcification. There is a consensus that the chronic overload of calcium and phosphorus is a major factor in vascular calcification. Hyperphosphatemia, deleterious in dialysis patients, is aggressively monitored and treated. Phosphate binders - designed to bind dietary phosphate and thus prevent its absorption, are ubiquitous in the dialysis patient population, and calcium-based phosphate binders are often first line therapy because they are tolerated well by the patients and low in cost. Phosphate Kinetic Modeling (PKM) is a tool to help physicians manage a hemodialysis patient's phosphate level. Once a subject consents to participate in the study, the subject's dietary phosphate intake will be estimated and the appropriate dose of the phosphate binder calcium acetate (PhosLo) will be recommended accordingly. If necessary, the Ca++ concentration of the dialysate will be changed to remove any excess calcium absorbed as the result of an increase in the PhosLo prescription to control phosphorus.Ongoing recommendations regarding oral phosphate binders dialysate calcium will be made using a computer generated algorithm.

Interventions

  • OTHER Computer algorithm management of hyperphosphatemia

Study Locations (1)

Massachusetts

  • Fresenius Medical Services - Waltham

Trial Details

FieldValue
Enrollment Target 190 participants
Start Date 2009-10
Est. Completion 2011-04
Phase NA

What the Registry Record Tells You About NCT01003223

The ClinicalTrials.gov registry entry for NCT01003223 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 831-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (77% lower). The listed sponsor is Fresenius Medical Care North America, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 1 intervention - of which Computer algorithm management of hyperphosphatemia is the first listed.

NCT01003223 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01003223 about?

NCT01003223 is a clinical study titled "Phosphate Kinetic Modeling". Cardiovascular disease is a major cause of death in hemodialysis (HD) patients and is associated with widespread vascular calcification. There is a consensus that the chronic overload of calcium and phosphorus is a major factor in vascular calcification. Hyperphosphatemia, deleterious in dialysis pa...

What is the current status of trial NCT01003223?

This trial is currently completed. It is a NA study. The enrollment target is 190 participants. The study started on 2009-10. Estimated completion is 2011-04.

What conditions does trial NCT01003223 study?

This clinical trial studies the following conditions: End Stage Renal Disease, Hyperphosphatemia.

What interventions are being tested in trial NCT01003223?

The interventions under investigation include: Computer algorithm management of hyperphosphatemia (OTHER).

Who is sponsoring clinical trial NCT01003223?

This trial is sponsored by Fresenius Medical Care North America, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01003223 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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