Fosrenol Post-marketing Surveillance in Japan

NCT ID: NCT01955876

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 343 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-10
• Study Completion Date: 2016-08-05

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Lanthanum Carbonate (Fosrenol, BAY77-1931)

Intervention Type: DRUG

Patients treated with Fosrenol in daily clinical practice.

Interventions

Lanthanum Carbonate (Fosrenol, BAY77-1931)

Patients treated with Fosrenol in daily clinical practice.

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Multiple Locations, , Japan

Countries

Japan

Other Identifiers

FOSRENOL-PRED

Identifier Type: OTHER

Identifier Source: secondary_id

16626

Identifier Type: -

Identifier Source: org_study_id