Fosrenol Post-marketing Surveillance for Hemodialysis in Japan

NCT ID: NCT01419327

Last Updated: 2020-05-20

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3267 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-23

Study Completion Date

2019-05-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperphosphatemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Drug (incl. Placebo)

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

Intervention Type DRUG

Patients in hemodialysis who have received Fosrenol for hyperphosphatemia.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Patients in hemodialysis who have received Fosrenol for hyperphosphatemia.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia

Exclusion Criteria

* Patients who are contraindicated based on the product label
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Multiple Locations, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Related Links

Access external resources that provide additional context or updates about the study.

http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15077

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.