Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan (FOSRENOL-CAPD)

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia
• Intervention / Treatment: Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet

• Study Type: Observational
• Enrollment (Actual): 446

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study is all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who are contraindicated based on the product label

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Drug (incl. Placebo)	Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet; Patients in CAPD who have received Fosrenol for hyperphosphatemia

What is the study measuring?

Primary Outcome Measures

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 Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2009
• Primary Completion (Actual): April 8, 2014
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: August 4, 2011
• First Submitted That Met QC Criteria: August 8, 2011
• First Posted (Estimate): August 9, 2011

Study Record Updates

• Last Update Posted (Actual): January 19, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Hyperphosphatemia; Fosrenol; Continuous Cyclic Peritoneal Dialysis
• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia
• Other Study ID Numbers: 15076