Phosphate Kinetic Modeling (PKM)
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|ClinicalTrials.gov Identifier: NCT01003223|
Recruitment Status : Completed
First Posted : October 28, 2009
Last Update Posted : August 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease Hyperphosphatemia||Other: Computer algorithm management of hyperphosphatemia||Not Applicable|
PKM consists of a set of validated and computerized algorithms to perform the following steps:
- Calculate calcium (Ca) and phosphorus (P) intake and absorption in individual patients as a function of the prescribed doses of Vitamin D analogues, protein catabolic rate (PCR) and dietary and binder Ca intakes.
- Calculate P removal between dialyses by P binders and P and Ca removal during dialysis from kinetic analysis of total P and Ca transport during dialysis based on dialyzer P and Ca transport coefficients and the levels of dialysate Ca and serum Ca and P.
- Thus from analysis of intake, absorption and removal the program can calculate net Ca and P balance in modeled patients.
- Calculate the dose of phosphate binder required to reduce the serum P to normal in patients with hyperphosphatemia.
- Calculate the dialysate Ca required to achieve zero calcium balance over complete dialysis cycles - the interdialytic interval and immediately succeeding dialytic interval.
- The program also computes a Phosphorus-Protein index (PPI, the total P removed divided by PCR, mg/gm/day) which provides a quantitative index of compliance with prescribed dietary P restriction and/or the prescribed dose of binders. If the PPI exceeds 18, the report indicates it is likely the patient is not in compliance with respect to prescribed diet and/or binder. It is hoped that this information will be valuable to guide semiquantitative evaluations of diet P and binder intakes in patients difficult to manage.
Patients will be modeled on a monthly basis from pre- and post-dialytic Ca, P, PCR and other routine data readily available such as blood and dialysate flow rates, fluid removal etc. A monthly report will be generated for the physician and staff by Norma Ofsthun, PhD containing the analyses and recommendations for any changes in therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||190 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phosphate Kinetic Modeling|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||April 2011|
|Experimental: PKM modeling with graphical report||
Other: Computer algorithm management of hyperphosphatemia
The PKM algorithm is a computer based program that calculates Phosphorus intake between dialysis, phosphorus reduction during dialysis treatment and daily oral phosphate binder intake compliance. Based on pre and post dialysis serum phosphorus levels, the algorithm makes recommendations in relation to dialysate calcium, oral phosphate binder use, and dietary counseling.
- The primary outcome variable is the change in serum phosphorus between a baseline period and the final 4 months of the study period. [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003223
|United States, Massachusetts|
|Fresenius Medical Services|
|Waltham, Massachusetts, United States, 02451|