Fosrenol Post-marketing Surveillance for Hemodialysis in Japan (FOSRENOL-HD)

May 18, 2020 updated by: Bayer

Special Drug Use Investigation of Fosrenol (Long-term Investigation for Patients With Hemodialysis)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3267

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Multiple Locations, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The target population of this study is patients who have received a prescription of Fosrenol on the basis of the decision of the physician. The study is expected to collect data of 3,000 patients in about 300 practices in Japan.

Description

Inclusion Criteria:

  • Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia

Exclusion Criteria:

  • Patients who are contraindicated based on the product label

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug (incl. Placebo)
Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
Patients in hemodialysis 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
Time Frame: After Fosrenol administration, up to 8 years
After Fosrenol administration, up to 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timing of onset of common ADRs related to the priority survey items
Time Frame: After Fosrenol administration, up to 8 years

The items are

  • Gastrointestinal symptoms
  • Secondary hyperparathyroidism
  • Hypocalcaemia and decreased blood calcium
After Fosrenol administration, up to 8 years
Effect on bones: Alkaline phosphatase over time
Time Frame: After Fosrenol administration, up to 8 years
After Fosrenol administration, up to 8 years
Effect on bones: Change in bone density
Time Frame: After Fosrenol administration, up to 8 years
After Fosrenol administration, up to 8 years
Cardiothoracic ratio over time
Time Frame: After Fosrenol administration, up to 8 years
After Fosrenol administration, up to 8 years
PWV and ABI over time
Time Frame: After Fosrenol administration, up to 8 years
After Fosrenol administration, up to 8 years
Serum P, albumin-corrected serum Ca and serum intact PTH, and Ca-P product over time
Time Frame: After Fosrenol administration, up to 8 years
After Fosrenol administration, up to 8 years
Percentage of patients achieving the serum P control goal
Time Frame: After Fosrenol administration, up to 8 years
After Fosrenol administration, up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2009

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

May 28, 2019

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

August 17, 2011

First Posted (Estimate)

August 18, 2011

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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