Status:
COMPLETED
Phosphate Kinetic Modeling
Lead Sponsor:
Fresenius Medical Care North America
Conditions:
End Stage Renal Disease
Hyperphosphatemia
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
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
- 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
- Parathyroidectomy
- iPTH \< 50 pg/mL
- Dialysate potassium prescription other than 2 or 3 mmol/L Corrected serum Ca++ \< 7.5 mg/dL
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT01003223
Start Date
October 1 2009
End Date
April 1 2011
Last Update
August 18 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fresenius Medical Services
Waltham, Massachusetts, United States, 02451