Status:
COMPLETED
A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Lead Sponsor:
Kissei Pharmaceutical Co., Ltd.
Conditions:
Hemodialysis
Hyperphosphatemia
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia
Eligibility Criteria
Inclusion
- Patients age 20 or older, regardless of gender.
- Receiving stable maintenance hemodialysis 3 times a week.
- Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.
Exclusion
- Patients having history of a pronounced brain / cardiovascular disorder.
- Patients having severe gastrointestinal disorders.
- Patients having severe hepatic disorders.
Key Trial Info
Start Date :
April 23 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2013
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT01850602
Start Date
April 23 2013
End Date
December 10 2013
Last Update
October 9 2018
Active Locations (1)
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1
Multiple Locations, Japan