Fosrenol Post-marketing Surveillance for Hemodialysis in Japan (FOSRENOL-HD)

Bayer

Status: Completed

Conditions: Hyperphosphatemia

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01419327

15077

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 hemodialysis who received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5 years.

Enrollment: 3,267 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia

Exclusion criteria

• Patients who are contraindicated based on the product label

Trial design

3,267 participants in 1 patient group

Group 1

Description:

Drug (incl. Placebo)

Treatment:

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