PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
1 other identifier
interventional
183
1 country
1
Brief Summary
To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2012
Shorter than P25 for phase_2
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
January 11, 2012
CompletedFirst Submitted
Initial submission to the registry
January 26, 2012
CompletedFirst Posted
Study publicly available on registry
January 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2012
CompletedResults Posted
Study results publicly available
August 23, 2018
CompletedAugust 23, 2018
November 1, 2017
6 months
January 26, 2012
November 27, 2017
November 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.
Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.
6 weeks
Secondary Outcomes (2)
Change From Baseline in Serum Calcium Concentrations.
6 weeks
Change From Baseline in Serum Intact-PTH Concentrations.
6 weeks
Study Arms (5)
PA21 750 mg/day
EXPERIMENTALPA21 1500 mg/day
EXPERIMENTALPA21 2250 mg/day
EXPERIMENTALPA21 3000 mg/day
EXPERIMENTALPlacebo
PLACEBO 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)
Japan
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
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Division
- Organization
- Kissei Pharmaceutical Co., Ltd
Study Officials
- STUDY DIRECTOR
Tatsuro Takei
Clinical Development Department, Kissei pharmaceutical Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2012
First Posted
January 30, 2012
Study Start
January 11, 2012
Primary Completion
July 3, 2012
Study Completion
July 3, 2012
Last Updated
August 23, 2018
Results First Posted
August 23, 2018
Record last verified: 2017-11