Back to resultsA Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia
Primary Purpose
Peritoneal Dialysis, Hyperphosphatemia
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
PA21
Sponsored by
About this trial
This is an interventional treatment trial for Peritoneal Dialysis focused on measuring Peritoneal Dialysis, Hyperphosphatemia
Eligibility Criteria
Inclusion Criteria:
- Receiving stable maintenance peritoneal dialysis
- Peritoneal dialysis patients with hyperphosphatemia
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 Type
Experimental
Arm Label
PA21
Arm Description
Outcomes
Primary Outcome Measures
Serum phosphate concentrations
Secondary Outcome Measures
Incidences of Adverse Events
Incidences of Adverse Events
Serum phosphate concentrations
Full Information
NCT ID
NCT01852682
First Posted
May 7, 2013
Last Updated
November 11, 2014
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01852682
Brief Title
A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
undefined (undefined)
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 investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis, Hyperphosphatemia
Keywords
Peritoneal Dialysis, Hyperphosphatemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
8. Arms, Groups, and Interventions
Arm Title
PA21
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PA21
Primary Outcome Measure Information:
Title
Serum phosphate concentrations
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Incidences of Adverse Events
Time Frame
12 weeks
Title
Incidences of Adverse Events
Time Frame
28 weeks
Title
Serum phosphate concentrations
Time Frame
28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Eligibility Criteria
Inclusion Criteria:
Receiving stable maintenance peritoneal dialysis
Peritoneal dialysis patients with hyperphosphatemia
Exclusion Criteria:
Patients having history of a pronounced brain / cardiovascular disorder
Patients having severe gastrointestinal disorders
Patients having severe hepatic disorders
Facility Information:
City
Tokyo and Other Japanese City
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia
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