Phosphate Kinetic Modeling (PKM)
Primary Purpose
End Stage Renal Disease, Hyperphosphatemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer algorithm management of hyperphosphatemia
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring phosphorus, dialysis, PhosLo, CKD stage V
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Thrice weekly hemodialysis with a dialysate Ca++ concentration (CdiCa) of 2.25 or 2.5 mEq/L
- Stable CdiCa of either 2.25 or 2.5 mEq/L for ≥ 4 weeks
- Dialysis vintage ≥ 6 months
- Current serum phosphorus ("month -1") > 5.5 mg/dL and average serum phosphorus month -1 to -3 > 5.5 mg/dL and average serum phosphorus month -1 to -6 > 5.5 mg/dL
- Patients currently prescribed calcium acetate (PhosLo) mono-therapy , sevelamer monotherapy, or a combination therapy of PhosLo plus sevelamer for phosphate binding
- Fresenius Optiflux F 160, 180 or 200 dialyzer
Exclusion Criteria:
- Parathyroidectomy
- iPTH < 50 pg/mL
- Dialysate potassium prescription other than 2 or 3 mmol/L Corrected serum Ca++ < 7.5 mg/dL
Sites / Locations
- Fresenius Medical Services
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PKM modeling with graphical report
Arm Description
Outcomes
Primary Outcome Measures
The primary outcome variable is the change in serum phosphorus between a baseline period and the final 4 months of the study period.
Secondary Outcome Measures
Full Information
NCT ID
NCT01003223
First Posted
October 27, 2009
Last Updated
August 14, 2014
Sponsor
Fresenius Medical Care North America
1. Study Identification
Unique Protocol Identification Number
NCT01003223
Brief Title
Phosphate Kinetic Modeling
Acronym
PKM
Official Title
Phosphate Kinetic Modeling
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Medical Care North America
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Hyperphosphatemia
Keywords
phosphorus, dialysis, PhosLo, CKD stage V
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PKM modeling with graphical report
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Computer algorithm management of hyperphosphatemia
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Thrice weekly hemodialysis with a dialysate Ca++ concentration (CdiCa) of 2.25 or 2.5 mEq/L
Stable CdiCa of either 2.25 or 2.5 mEq/L for ≥ 4 weeks
Dialysis vintage ≥ 6 months
Current serum phosphorus ("month -1") > 5.5 mg/dL and average serum phosphorus month -1 to -3 > 5.5 mg/dL and average serum phosphorus month -1 to -6 > 5.5 mg/dL
Patients currently prescribed calcium acetate (PhosLo) mono-therapy , sevelamer monotherapy, or a combination therapy of PhosLo plus sevelamer for phosphate binding
Fresenius Optiflux F 160, 180 or 200 dialyzer
Exclusion Criteria:
Parathyroidectomy
iPTH < 50 pg/mL
Dialysate potassium prescription other than 2 or 3 mmol/L Corrected serum Ca++ < 7.5 mg/dL
Facility Information:
Facility Name
Fresenius Medical Services
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
12. IPD Sharing Statement
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Phosphate Kinetic Modeling
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