Back to resultsA Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Primary Purpose
Hemodialysis, Hyperphosphatemia
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
PA21
Sevelamer hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Hemodialysis focused on measuring Hemodialysis, Hyperphosphatemia
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- Patients having history of a pronounced brain / cardiovascular disorder.
- Patients having severe gastrointestinal disorders.
- Patients having severe hepatic disorders.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PA21
Sevelamer hydrochloride
Arm Description
Outcomes
Primary Outcome Measures
Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment
Covariate: Serum phosphorus concentrations at baseline.
Secondary Outcome Measures
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
Full Information
NCT ID
NCT01850602
First Posted
May 7, 2013
Last Updated
March 2, 2018
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01850602
Brief Title
A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 23, 2013 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 10, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis, Hyperphosphatemia
Keywords
Hemodialysis, Hyperphosphatemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PA21
Arm Type
Experimental
Arm Title
Sevelamer hydrochloride
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PA21
Intervention Type
Drug
Intervention Name(s)
Sevelamer hydrochloride
Primary Outcome Measure Information:
Title
Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment
Description
Covariate: Serum phosphorus concentrations at baseline.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
Time Frame
12 weeks
Title
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
Time Frame
12 weeks
Title
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
Patients having history of a pronounced brain / cardiovascular disorder.
Patients having severe gastrointestinal disorders.
Patients having severe hepatic disorders.
Facility Information:
City
Multiple Locations
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
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