A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
1 other identifier
interventional
213
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2013
CompletedFirst Submitted
Initial submission to the registry
May 7, 2013
CompletedFirst Posted
Study publicly available on registry
May 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2013
CompletedResults Posted
Study results publicly available
October 9, 2018
CompletedOctober 9, 2018
November 1, 2014
7 months
May 7, 2013
March 2, 2018
March 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment
Covariate: Serum phosphorus concentrations at baseline.
12 weeks
Secondary Outcomes (3)
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
12 weeks
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
12 weeks
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
12 weeks
Study Arms (2)
PA21
EXPERIMENTALSevelamer hydrochloride
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients having history of a pronounced brain / cardiovascular disorder.
- Patients having severe gastrointestinal disorders.
- Patients having severe hepatic disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Multiple Locations, Japan
Related Publications (1)
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Division
- Organization
- Kissei Pharmaceutical Co., Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2013
First Posted
May 9, 2013
Study Start
April 23, 2013
Primary Completion
December 1, 2013
Study Completion
December 10, 2013
Last Updated
October 9, 2018
Results First Posted
October 9, 2018
Record last verified: 2014-11