Fosrenol Post-marketing Surveillance for Hemodialysis in Japan

Completed

• Conditions: Hyperphosphatemia
• Interventions: Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet

• Registration Number: NCT01419327
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-23
• Study First Submitted: 2011-08-17
• Study First Submitted QC: 2011-08-17
• Study First Posted: 2011-08-18
• Primary Completion: 2019-01-30
• Study Completion: 2019-05-28
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3267

Inclusion Criteria

• Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia

Read More

Exclusion Criteria

• Patients who are contraindicated based on the product label

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet	Drug (incl. Placebo)

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions in subjects who received Fosrenol	After Fosrenol administration, up to 8 years

Secondary Outcome Measures

Name	Time	Method
Timing of onset of common ADRs related to the priority survey items	After Fosrenol administration, up to 8 years	The items are; * Gastrointestinal symptoms; * Secondary hyperparathyroidism; * Hypocalcaemia and decreased blood calcium
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