Fosrenol Post-marketing Surveillance in Japan

Bayer

Status: Completed

Conditions: Hyperphosphatemia; Kidney Disease

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01955876

FOSRENOL-PRED (Other Identifier)

16626

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 who have received Fosrenol.

The objective of this research is to collect information on the safety of Fosrenol after its launching, which means collecting information on adverse events, especially adverse events in the digestive system including constipation and serious adverse events, and adverse drug reactions when the drug is administered to the below-mentioned target patients for six months.

The secondary objective is to collect information on the safety of the drug when administered for more than six months, which means collecting information on the safety of the drug when administered for up to 12 months to the target patients who have already been treated with the drug for six months. And also if at the time of 12 months after administration of Lanthanum carbonate the dialysis is not conducted, extending its' administration will be continued until conduction of dialysis, or until Sept. 30, 2015. The efficacy of fosrenol is evaluated by observing the serum P(phosphorus) level and serum PTH (parathyroid hormone) level change.

Enrollment: 343 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients whom investigators have decided to treat with Lanthanum carbonate for the first time at the respective medical institutions. Those medical institutions have to understand the objective of this investigation and conclude a written contract with Bayer Yakuhin.
• The decision to treat patients with Lanthanum carbonate will be made independently by the investigator prior to study inclusion.
• Patients treated with Lanthanum carbonate in the indication "Hyperphosphatemia" with chronic kidney disease not on dialysis".

Exclusion criteria

• Patients who are contraindicated based on the product label.
• Patients who have been already treated with Fosrenol

Trial design

343 participants in 1 patient group

Group 1

Treatment:

Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931)