NCT01955876

Fosrenol Post-marketing Surveillance in Japan

Drug Use Investigation of Fosrenol for Hyperphosphatemia With Chronic Kidney Disease Not on Dialysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 343 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hyperphosphatemia
• Kidney Disease

Interventions

Type	Name	Description
DRUG	Lanthanum Carbonate (Fosrenol, BAY77-1931)	Patients treated with Fosrenol in daily clinical practice.

Timeline

• Start date: 2013-10-10
• Primary completion: 2016-02-18
• Completion: 2016-08-05
• First posted: 2013-10-08
• Last updated: 2018-02-23

Locations

1 site across 1 country: Japan