Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With Hemodialysis)

Fosrenol Post-marketing Surveillance for Hemodialysis in Japan

Sponsors

Lead sponsor: Bayer

Source Bayer
Brief Summary

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.

Overall Status Completed
Start Date March 23, 2009
Completion Date May 28, 2019
Primary Completion Date January 30, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Incidence of adverse drug reactions in subjects who received Fosrenol After Fosrenol administration, up to 8 years
Secondary Outcome
Measure Time Frame
Timing of onset of common ADRs related to the priority survey items After Fosrenol administration, up to 8 years
Effect on bones: Alkaline phosphatase over time After Fosrenol administration, up to 8 years
Effect on bones: Change in bone density After Fosrenol administration, up to 8 years
Cardiothoracic ratio over time After Fosrenol administration, up to 8 years
PWV and ABI over time After Fosrenol administration, up to 8 years
Serum P, albumin-corrected serum Ca and serum intact PTH, and Ca-P product over time After Fosrenol administration, up to 8 years
Percentage of patients achieving the serum P control goal After Fosrenol administration, up to 8 years
Enrollment 3267
Condition
Intervention

Intervention type: Drug

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

Description: Patients in hemodialysis who have received Fosrenol for hyperphosphatemia.

Arm group label: Group 1

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia

Exclusion Criteria:

- Patients who are contraindicated based on the product label

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Bayer Study Director Study Director Bayer
Location
facility
Location Countries

Japan

Verification Date

May 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Group 1

Description: Drug (incl. Placebo)

Acronym FOSRENOL-HD
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov