- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01057407
A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis
April 30, 2015 updated by: Astellas Pharma Inc
A Phase 3, Multicenter, Open-label, Sevelamer Hydrochloride-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia on Hemodialysis
This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on hemodialysis.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
110
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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Chubu, Japan
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Kantou, Japan
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Kyusyu, 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:
- Chronic kidney disease patients on hemodialysis
- Hyperphosphatemia
- Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not been changed within 28 days
- Written informed consent
Exclusion Criteria:
- Patients with gastrointestinal surgery or enterectomy
- Patients with severe cardiac diseases
- Patients with severe constipation or diarrhea
- Patients with a history or complication of malignant tumors
- Patients with uncontrolled hypertension
- Patients treated with parathyroid intervention
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ASP group
|
oral
Other Names:
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Active Comparator: Sevelamer group
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oral
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum phosphorus level at the end of treatment
Time Frame: After 12-week or at the treatment discontinuation
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After 12-week or at the treatment discontinuation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in serum phosphorus level
Time Frame: After 12-week or at the end of treatment
|
After 12-week or at the end of treatment
|
Time-course changes in serum phosphorus levels
Time Frame: During Treatment
|
During Treatment
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Changes in serum Ca x P
Time Frame: During treatment
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During treatment
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Changes in intact PTH levels
Time Frame: During Treatment
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During Treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
January 25, 2010
First Submitted That Met QC Criteria
January 25, 2010
First Posted (Estimate)
January 27, 2010
Study Record Updates
Last Update Posted (Estimate)
May 4, 2015
Last Update Submitted That Met QC Criteria
April 30, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1585-CL-0003
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.
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