Back to resultsA Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis
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, Peritoneal dialysis, CKD, ASP1585
Eligibility Criteria
Inclusion Criteria:
- Chronic kidney disease patients on peritoneal dialysis
- Hyperphosphatemia
- Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not 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 Type
Experimental
Arm Label
ASP group
Arm Description
Outcomes
Primary Outcome Measures
Serum phosphorus level at treatment discontinuation
Secondary Outcome Measures
Percent of the patients meeting the target range of serum phosphorus levels
Time-course changes in serum calcium levels
Changes in serum Ca x P
Changes in intact PTH levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01017276
Brief Title
A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis
Official Title
A Phase 3 Study in Patients With Chronic Kidney Disease (CKD) With Hyperphosphatemia on Peritoneal Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 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 in chronic kidney disease and hyperphosphatemia patients on peritoneal dialysis.
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, Peritoneal dialysis, CKD, ASP1585
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASP group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ASP1585
Other Intervention Name(s)
ILY101, AMG223
Intervention Description
oral
Primary Outcome Measure Information:
Title
Serum phosphorus level at treatment discontinuation
Time Frame
During the 12-week treatment period
Secondary Outcome Measure Information:
Title
Percent of the patients meeting the target range of serum phosphorus levels
Time Frame
During treatment
Title
Time-course changes in serum calcium 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 peritoneal dialysis
Hyperphosphatemia
Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not 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
Chugoku
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 150710 in the JapicCTI-RNo. field (Japanese record)
Learn more about this trial
A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis
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