NCT01252771|CompletedPhase 4
Phosphate Kinetic Modeling 2
PKM2
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PKM2
Sponsor study identifier
interventional
81
1 country
1
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2011
Actual (reported)Study Completion
December 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
December 1, 2010
Actual (reported)December 3, 2010
Actual (reported)September 2011
Actual (reported)December 2011
Actual (reported)change in serum phosphorus
The primary outcome variable is the change in serum phosphorus between a baseline period and the latest value of the intervention period.
6 months
Phosphate kinetic modeling was performed and displayed in graphical form laboratory results and an estimated phophorus protein ratio
The subject's serum calcium and phosphorus values will be input into PKM in order to determine the required PhosLo prescription. The prescription is determined as the number of gelcaps per day that must be taken by the subject. If PKM determines the number of PhosLo gelcaps per day to be greater than or equal to the subject's current prescription, then PKM will calculate the current Ca++ and phosphate balance. Furthermore, the PKM algorithm will determine the additional number of PhosLo gelcaps needed to achieve neutral phosphate (P) balance with serum P reduced to 5.5 mg/dL. The PKM algorithm also calculates the total P intake between dialyses and along with ePCR also calculates a Phosphorus/Protein Ratio (PPR). This ratio ranges from 8 to 14 in dialysis patients following a renal diet.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Renal Research Insitutue
New York, New York, 10128, United States
Peter Kotanko, MD
Renal Research Institute
81 participants (actual enrollment reported by the registry).
First Submitted
December 1, 2010
First Posted
December 3, 2010
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients
Contact the study team to confirm eligibility.
Primary Completion
September 2011
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
August 18, 2014
Record last verified: 2011-06
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Source: ClinicalTrials.gov.
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