Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease
Long-Term Specified Drug Use-Results Survey in Patients With Pre-dialysis Chronic Kidney Disease
1 other identifier
observational
144
1 country
14
Brief Summary
The objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2016
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 16, 2016
CompletedFirst Posted
Study publicly available on registry
June 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedOctober 16, 2024
April 1, 2019
2.6 years
June 16, 2016
October 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change from baseline in the serum concentrations of phosphate
Baseline and up to Month 12
Change from baseline in the corrected serum concentrations of calcium
Baseline and up to Month 12
Change from baseline in the serum concentrations of intact parathyroid hormone
Baseline and up to Month 12
Safety assessed by incidence of adverse events
Up to Month 12
Study Arms (1)
Chronic kidney disease
Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time.
Interventions
Eligibility Criteria
Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time
You may qualify if:
- Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Site JP00006
Aichi, Japan
Site JP00010
Ehime, Japan
Site JP00012
Fukuoka, Japan
Site JP00004
Gifu, Japan
Site JP00001
Ibaraki, Japan
Site JP00009
Kagawa, Japan
Site JP00003
Kanagawa, Japan
Site JP00011
Kochi, Japan
Site JP00014
Kumamoto, Japan
Site JP00013
Nagasaki, Japan
Site JP00007
Osaka, Japan
Site JP00005
Shizuoka, Japan
Site JP00002
Tochigi, Japan
Site JP00008
Wakayama, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2016
First Posted
June 20, 2016
Study Start
June 1, 2016
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
October 16, 2024
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.