Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan

Special Drug Use Investigation of Fosrenol (Investigation for Patients With Continuous Ambulatory Peritoneal Dialysis)

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 continuous ambulatory peritoneal dialysis (CAPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. This study is also all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited and followed one year.

Overall Status Completed
Start Date April 7, 2009
Completion Date September 1, 2016
Primary Completion Date April 8, 2014
Study Type Observational
Primary Outcome
Measure Time Frame
Incidence of adverse drug reactions in subjects who received Fosrenol After Fosrenol administration, up to 1 year
Incidence of serious adverse events in subjects who received Fosrenol After Fosrenol administration, up to 1 year
Secondary Outcome
Measure Time Frame
Incidence of adverse drug reactions in subpopulation with baseline data [such as demographic data, concomitant disease, duration of treatment, maximum daily dose] and dose of Fosrenol After Fosrenol administration, up to 1 year
Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL] After Fosrenol administration, up to 1 year
Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL] After Fosrenol administration, up to 1 year
Clinical test value collections [calciotropic hormones, bone turnover markers] After Fosrenol administration, up to 1 year
Enrollment 446
Condition
Intervention

Intervention Type: Drug

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

Description: Patients in CAPD who have received Fosrenol for hyperphosphatemia

Arm Group Label: Group 1

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Patients undergoing continuous ambulatory peritoneal dialysis who received Fosrenol for hyperphosphatemia

Exclusion Criteria:

- Patients who are contraindicated based on the product label

Gender: All

Minimum Age: 13 Years

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

January 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Group 1

Description: Drug (incl. Placebo)

Acronym FOSRENOL-CAPD
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov