Phosphate Kinetic Modeling 2

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01252771
• Date of registration: 01/12/2010
• Primary sponsor: Fresenius Medical Care North America
• Public title: Phosphate Kinetic Modeling 2 PKM2
• Scientific title: Phosphate Kinetic Modeling 2
• Date of first enrolment: September 2010
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01252771
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Peter Kotanko, MD
• Affiliation: Renal Research Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject is capable of giving informed consent.

2. Age > 18 years

3. Thrice weekly hemodialysis with a dialysate Ca++ concentration (CdiCa) of 2.0, 2.25
or 2.5 mEq/L

4. Stable CdiCa of either 2.0, 2.25 or 2.5 mEq/L for = 4 weeks

5. Dialysis vintage = 3 months

6. Three-month average P > 5.5 mg/dL AND 2 of 3 monthly average P >=5.8 mg/dL

7. 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

8. Fresenius Optiflux F 160, 180 or 200 dialyzer

Exclusion Criteria:

1. 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

2. Known pregnancy

3. Parathyroidectomy

4. iPTH < 50 pg/mL

5. Hospitalization in past 30 days

6. Dialysate potassium prescription other than 2 or 3 mmol/L

7. Serum Ca++ < 7.5 mg/dL

8. Current vitamin D therapy using calcitriol



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

ESRD

Hyperphosphatemia

Intervention(s)

Other: PKM Algorithm

Primary Outcome(s)

change in serum phosphorus [Time Frame: 6 months]

Secondary ID(s)

10-188

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Renal Research Institute