Back to resultsA Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis
Primary Purpose
Chronic Kidney Disease, Renal Dialysis, Renal Insufficiency
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
ASP1585
Sevelamer hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Hyperphosphatemia, hemodialysis, CKD, ASP1585
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ASP group
Sevelamer group
Arm Description
Outcomes
Primary Outcome Measures
Serum phosphorus level at the end of treatment
Secondary Outcome Measures
Change in serum phosphorus level
Time-course changes in serum phosphorus levels
Changes in serum Ca x P
Changes in intact PTH levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01057407
Brief Title
A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis
Official Title
A Phase 3, Multicenter, Open-label, Sevelamer Hydrochloride-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia on Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Renal Dialysis, Renal Insufficiency
Keywords
Hyperphosphatemia, hemodialysis, CKD, ASP1585
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASP group
Arm Type
Experimental
Arm Title
Sevelamer group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ASP1585
Other Intervention Name(s)
ILY101, AMG223
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Sevelamer hydrochloride
Other Intervention Name(s)
Renagel, phosbloc
Intervention Description
oral
Primary Outcome Measure Information:
Title
Serum phosphorus level at the end of treatment
Time Frame
After 12-week or at the treatment discontinuation
Secondary Outcome Measure Information:
Title
Change in serum phosphorus level
Time Frame
After 12-week or at the end of treatment
Title
Time-course changes in serum phosphorus levels
Time Frame
During Treatment
Title
Changes in serum Ca x P
Time Frame
During treatment
Title
Changes in intact PTH levels
Time Frame
During Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu
Country
Japan
City
Kantou
Country
Japan
City
Kyusyu
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch.jsp
Description
Link to Results on JAPIC - enter 150708 in the JapicCTI-RNo. field (Japanese record)
Learn more about this trial
A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis
We'll reach out to this number within 24 hrs