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NCT01252771 · ClinicalTrials.gov registry record · Phase 4
Phosphate Kinetic Modeling 2
A Phase 4 study of ESRD and Hyperphosphatemia, sponsored by Fresenius Medical Care North America.
- Completed
- Registry status
- Phase 4
- Development phase
- 81
- Enrollment target
- 1
- Study location
NCT01252771: Completed Phase 4 study of ESRD and Hyperphosphatemia, sponsored by Fresenius Medical Care North America.
NCT01252771 is a Phase 4 study of ESRD and Hyperphosphatemia that has completed, run by Fresenius Medical Care North America. The registered enrollment target is 81 participants, below the 135-participant average among 13 other ESRD trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01252771, a Phase 4 study of ESRD and Hyperphosphatemia, has completed, sponsored by Fresenius Medical Care North America.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 81 participants
- Enrollment target
- 1
- Study location
Study Summary
The study aims to investigate the concept of computer based Phosphate Kinetic Modeling (PKM) in the hemodialysis patient population. This computerized algorithm model was developed as a tool to aid physicians in controlling a hemodialysis patient's phosphate level. Once a subject consents to participate in the study, the subject's dietary phosphate intake will be estimated by the modeling program 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.
Primary Outcome
The primary outcome variable is the change in serum phosphorus between a baseline period and the latest value of the intervention period.
Conditions Studied
Interventions
- OTHER PKM Algorithm
Study Locations (1)
New York
- Renal Research Insitutue - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-12 |
| Phase | Phase 4 |
What the finished NCT01252771 record still lists
NCT01252771 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 135-participant average among 13 other ESRD trials with a reported enrollment target (40% lower).
The record links to 2 conditions, with ESRD appearing as the primary indexed condition, and to 1 intervention - of which PKM Algorithm is the first listed.
NCT01252771 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01252771 about?
NCT01252771 is a clinical study titled "Phosphate Kinetic Modeling 2". The study aims to investigate the concept of computer based Phosphate Kinetic Modeling (PKM) in the hemodialysis patient population. This computerized algorithm model was developed as a tool to aid physicians in controlling a hemodialysis patient's phosphate level. Once a subject consents to partici...
What is the current status of trial NCT01252771?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 81 participants. The study started on 2010-09. Estimated completion is 2011-12.
What conditions does trial NCT01252771 study?
This clinical trial studies the following conditions: ESRD, Hyperphosphatemia.
What interventions are being tested in trial NCT01252771?
The interventions under investigation include: PKM Algorithm (OTHER).
Who is sponsoring clinical trial NCT01252771?
This trial is sponsored by Fresenius Medical Care North America, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01252771 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01252771's enrollment target sits among peer trials
81 9th of 13 higher than 5 of 13 other ESRD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other ESRD 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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