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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01412398

Acronym

FOSRENOL-CAPD

Enrollment

446

Registered

2011-08-09

Start date

2009-04-07

Completion date

2016-09-01

Last updated

2018-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperphosphatemia

Keywords

Fosrenol, Hyperphosphatemia, Continuous Cyclic Peritoneal Dialysis

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.

Interventions

DRUGLanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet

Patients in CAPD who have received Fosrenol for hyperphosphatemia

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Patients who are contraindicated based on the product label

Design outcomes

Primary

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

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026