Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
Primary Purpose
Chronic Kidney Disease, Renal Dialysis, Renal Insufficiency
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
ASP1585
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
- Written informed consent
Exclusion Criteria:
- Patients with gastrointestinal surgery or enterectomy
- Severe cardiac disease patients
- Patients with severe constipation or diarrhea
- Patients with a complication of malignant tumors
- Patients with uncontrolled hypertension
- Patients treated with parathyroid intervention
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1. ASP1585
Arm Description
Outcomes
Primary Outcome Measures
Changes in serum Phosphorus level
Secondary Outcome Measures
Percent of the patients meeting the target range of serum Phosphorus levels
Changes in serum Calcium level
Changes in serum Ca x P
Changes in intact PTH level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00892749
Brief Title
Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
Official Title
A Phase 3, Long-term Study in Patients With Chronic Kidney Disease (CKD) and Hyperphosphatemia on Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (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, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease and hyperphosphatemia patients 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, Hyperphosphatemia
Keywords
hyperphosphatemia, hemodialysis, CKD, ASP1585
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. ASP1585
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ASP1585
Other Intervention Name(s)
ILY101, AMG223
Intervention Description
oral
Primary Outcome Measure Information:
Title
Changes in serum Phosphorus level
Time Frame
After 48 weeks
Secondary Outcome Measure Information:
Title
Percent of the patients meeting the target range of serum Phosphorus levels
Time Frame
During the treatment
Title
Changes in serum Calcium level
Time Frame
After 48 weeks
Title
Changes in serum Ca x P
Time Frame
After 48 weeks
Title
Changes in intact PTH level
Time Frame
After 48 weeks
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
Written informed consent
Exclusion Criteria:
Patients with gastrointestinal surgery or enterectomy
Severe cardiac disease patients
Patients with severe constipation or diarrhea
Patients with a 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
Chugoku
Country
Japan
City
Kansai
Country
Japan
City
Kantou
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch.jsp
Description
Link to Results on JAPIC - enter 150709 in the JapicCTI-RNo. field (Japanese record)
Learn more about this trial
Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
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