Hyperphosphatemia
Conditions
Brief summary
Patients who have been treated with Fosrenol for a minimum of 12 consecutive weeks and are receiving dialysis will be followed for 5 years to compare mortality, bone fractures and incidence of selected morbidities to patients with no lanthanum exposure and to patients being treated for hyperphosphatemia with any marketed product.
Interventions
None listed
Sponsors
Shire
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Test Group * Signed informed consent * Patient must have ESRD and be receiving dialysis * Prior treatment with Fosrenol for a minimum of 12 consecutive weeks * Primary payer of healthcare must be Medicare (patient must supply Medicare Claim Number) * Patient must be 18 years of age or older
Exclusion criteria
Test Group * Patients that do not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD) | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Compare the incidence of selected morbidities among three groups of patients with ESRD | 5 years |
Countries
United States
Outcome results
None listed