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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: Completed NA study of End Stage Renal Disease and Hyperphosphatemia, sponsored by Fresenius Medical Care North America.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
Interventions
- OTHER Computer algorithm management of hyperphosphatemia
Study Locations (1)
Massachusetts
- Fresenius Medical Services - Waltham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-04 |
| Phase | NA |
What the finished NCT01003223 record still lists
NCT01003223 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 831-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01003223's enrollment target sits among peer trials
190 21st of 86 higher than 66 of 86 other End Stage Renal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease 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.
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