Long Term Treatment of End Stage Renal Disease Patients With Lanthanum Carbonate (Fosrenol)

Shire

Status: Completed

Conditions: Hyperphosphatemia

Study type: Observational

Funder types: Industry

Identifiers

NCT00567723

SPD405-404

Details and patient eligibility

About

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.

Enrollment: 2,105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

2,105 participants in 3 patient groups

1

Description:

Test group: Patients who have received a minimum of 12 consecutive weeks of treatment with Fosrenol

2

Description:

Historical control group: Patients with no lanthanum exposure

3

Description:

Concomitant therapy group: Patients being treated for hyperphosphatemia with any marketed product