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NCT02805348 Clinical Trial

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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02805348
Other study ID # 1585-MA-3052
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2016
Est. completion date December 31, 2018

Study information
Verified date April 2019
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 144
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bixalomer
Oral

Locations
Country Name City State
Japan 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

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

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