Phosphate Kinetic Modeling 2

NCT01252771 | Completed Phase 4

• 1 other identifier: 10-188
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hyperphosphatemia; ESRD

Keywords

phosphorus; dialysis; PhosLo

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PKM report and algorithm

EXPERIMENTAL

Phosphate kinetic modeling was performed and displayed in graphical form laboratory results and an estimated phophorus protein ratio

Other: PKM Algorithm

Interventions

PKM Algorithm OTHER

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.

PKM report and algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care North America: lead
• Renal Research Institute: collaborator

Study Sites (1)

Renal Research Insitutue

New York, New York, 10128, United States

Location

MeSH Terms

Conditions

Hyperphosphatemia; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Kotanko, MD

  Renal Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 3, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 18, 2014

Record last verified: 2011-06

Locations

US (1)