Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan (FOSRENOL-CAPD)

Bayer

Status: Completed

Conditions: Hyperphosphatemia

Treatments: Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet

Study type: Observational

Funder types: Industry

Identifiers

NCT01412398

15076

Details and patient eligibility

About

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in continuous ambulatory peritoneal dialysis (CAPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. This study is also all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited and followed one year.

Enrollment: 446 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing continuous ambulatory peritoneal dialysis who received Fosrenol for hyperphosphatemia

Exclusion criteria

• Patients who are contraindicated based on the product label

Trial design

446 participants in 1 patient group

Group 1

Description:

Drug (incl. Placebo)

Treatment:

Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet