- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01833494
A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
March 2, 2018 updated by: Kissei Pharmaceutical Co., Ltd.
The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
161
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Multiple Locations, Japan
- Japan
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Receiving stable maintenance hemodialysis 3 times a week.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PA21
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Adverse Events
Time Frame: 52 weeks
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
Time Frame: 52 weeks
|
52 weeks
|
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
Time Frame: 52 weeks
|
52 weeks
|
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
Time Frame: 52 weeks
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2013
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 4, 2014
Study Registration Dates
First Submitted
April 12, 2013
First Submitted That Met QC Criteria
April 16, 2013
First Posted (Estimate)
April 17, 2013
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
March 2, 2018
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA1302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemodialysis Patients With Hyperphosphatemia
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Taisho Pharmaceutical Co., Ltd.CompletedHyperphosphatemia Patients on HemodialysisJapan
-
Astellas Pharma IncCompletedChronic Kidney Disease Patients on Hemodialysis With HyperphosphatemiaJapan
-
Astellas Pharma IncCompletedChronic Renal Failure Patients With Hyperphosphataemia Receiving HemodialysisJapan
-
Chugai PharmaceuticalCompleted
-
Ain Shams UniversityNot yet recruitingHemodialysis Patients
-
Institut Phoceen de NephrologieRecruiting
-
Dong-A ST Co., Ltd.CompletedThe Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Evogliptin in Hemodialysis PatientsHemodialysis PatientsKorea, Republic of
-
Hospital de Clinicas de Porto AlegreUnknown
-
Ataturk UniversityRecruiting
-
Mansoura UniversityNot yet recruitingHemodialysis Patients
Clinical Trials on PA21
-
Kissei Pharmaceutical Co., Ltd.CompletedPeritoneal Dialysis | HyperphosphatemiaJapan
-
Kissei Pharmaceutical Co., Ltd.CompletedChronic Kidney Disease Requiring HemodialysisJapan
-
Vifor Fresenius Medical Care Renal PharmaCompletedHyperphosphatemiaSpain, Netherlands, Germany, Italy, France, Greece, United Kingdom
-
Vifor PharmaCompletedChronic Kidney DiseaseUnited States, Switzerland, Romania, Croatia, Bulgaria, Germany, Czech Republic, Poland, Russian Federation
-
Vifor PharmaCompleted
-
Vifor PharmaCompleted
-
Kissei Pharmaceutical Co., Ltd.CompletedHemodialysis | HyperphosphatemiaJapan
-
Vifor PharmaFresenius Medical Care North AmericaCompletedChronic Kidney Disease Requiring Chronic DialysisLatvia, United States, Belgium, Croatia, Austria, Czech Republic, Germany, Lithuania, Poland, Romania, Russian Federation, Serbia, South Africa, Ukraine, United Kingdom