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

NCT ID: NCT01412398

Last Updated: 2018-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

446 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-07

Study Completion Date

2016-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperphosphatemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Drug (incl. Placebo)

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

Intervention Type DRUG

Patients in CAPD who have received Fosrenol for hyperphosphatemia

Interventions

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

Patients in CAPD who have received Fosrenol for hyperphosphatemia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients who are contraindicated based on the product label
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Multiple Locations, , Japan

Site Status

Countries

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Japan

Other Identifiers

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15076

Identifier Type: -

Identifier Source: org_study_id

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