Phosphate Kinetic Modeling

NCT01003223 | Completed

• 1 other identifier: NEIRB PKM 09-207
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Hyperphosphatemia

Keywords

phosphorus; dialysis; PhosLo; CKD stage V

Outcome Measures

Primary Outcomes (1)

• The primary outcome variable is the change in serum phosphorus between a baseline period and the final 4 months of the study period.

  6 months

Study Arms (1)

PKM modeling with graphical report

EXPERIMENTAL

Other: Computer algorithm management of hyperphosphatemia

Interventions

Computer algorithm management of hyperphosphatemia OTHER

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.

PKM modeling with graphical report

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Parathyroidectomy
• iPTH \< 50 pg/mL
• Dialysate potassium prescription other than 2 or 3 mmol/L Corrected serum Ca++ \< 7.5 mg/dL

Sponsors & Collaborators

• Fresenius Medical Care North America: lead

Study Sites (1)

Fresenius Medical Services

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Hyperphosphatemia

Condition Hierarchy (Ancestors)

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; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: October 28, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: April 1, 2011
• Last Updated: August 18, 2014

Record last verified: 2010-11

Locations

US (1)