Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease

April 2, 2019 updated by: Astellas Pharma Inc

Long-Term Specified Drug Use-Results Survey in Patients With Pre-dialysis Chronic Kidney Disease

The objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

144

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
      • Aichi, Japan
        • Site JP00006
      • Ehime, Japan
        • Site JP00010
      • Fukuoka, Japan
        • Site JP00012
      • Gifu, Japan
        • Site JP00004
      • Ibaraki, Japan
        • Site JP00001
      • Kagawa, Japan
        • Site JP00009
      • Kanagawa, Japan
        • Site JP00003
      • Kochi, Japan
        • Site JP00011
      • Kumamoto, Japan
        • Site JP00014
      • Nagasaki, Japan
        • Site JP00013
      • Osaka, Japan
        • Site JP00007
      • Shizuoka, Japan
        • Site JP00005
      • Tochigi, Japan
        • Site JP00002
      • Wakayama, Japan
        • Site JP00008

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

Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time

Description

Inclusion Criteria:

  • Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic kidney disease
Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time.
Drug: Bixalomer
Oral
Other Names:
  • Kiklin
  • ILY101
  • AMG223
  • ASP1585

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the serum concentrations of phosphate
Time Frame: Baseline and up to Month 12
Baseline and up to Month 12
Change from baseline in the corrected serum concentrations of calcium
Time Frame: Baseline and up to Month 12
Baseline and up to Month 12
Change from baseline in the serum concentrations of intact parathyroid hormone
Time Frame: Baseline and up to Month 12
Baseline and up to Month 12
Safety assessed by incidence of adverse events
Time Frame: Up to Month 12
Up to Month 12

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

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)

June 1, 2016

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 3, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1585-MA-3052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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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