Status:
COMPLETED
Phosphate Kinetic Modeling 2
Lead Sponsor:
Fresenius Medical Care North America
Collaborating Sponsors:
Renal Research Institute
Conditions:
Hyperphosphatemia
ESRD
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ph...
Detailed Description
PKM consists of a set of validated and computerized algorithms to perform the following steps: 1. Calculate calcium (Ca) and phosphorus (P) intake and absorption in individual patients as a function ...
Eligibility Criteria
Inclusion
- Subject is capable of giving informed consent.
- Age \> 18 years
- Thrice weekly hemodialysis with a dialysate Ca++ concentration (CdiCa) of 2.0, 2.25 or 2.5 mEq/L
- Stable CdiCa of either 2.0, 2.25 or 2.5 mEq/L for ≥ 4 weeks
- Dialysis vintage ≥ 3 months
- Three-month average P \> 5.5 mg/dL AND 2 of 3 monthly average P \>=5.8 mg/dL
- Patients currently prescribed calcium acetate (PhosLo) mono-therapy , sevelamer monotherapy, or a combination therapy of PhosLo plus sevelamer for phosphate binding with willingness of physician to switch to PhosLo monotherapy
- Fresenius Optiflux F 160, 180 or 200 dialyzer
Exclusion
- Any laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
- Known pregnancy
- Parathyroidectomy
- iPTH \< 50 pg/mL
- Hospitalization in past 30 days
- Dialysate potassium prescription other than 2 or 3 mmol/L
- Serum Ca++ \< 7.5 mg/dL
- Current vitamin D therapy using calcitriol
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01252771
Start Date
September 1 2010
End Date
December 1 2011
Last Update
August 18 2014
Active Locations (1)
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1
Renal Research Insitutue
New York, New York, United States, 10128