Back to resultsLong-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
Primary Purpose
Chronic Kidney Disease, Renal Insufficiency, Hyperphosphatemia
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 CKD, Not on dialysis, ASP1585, Bixalomer
Eligibility Criteria
Inclusion Criteria:
- Patients who completed study 1585-CL-0101 or new patients who meet following criteria
- Chronic kidney disease patients (eGFR < 60 mL/min/1.73 m2)
- Serum phosphorus measurement ≧4.6 mg/dl, <9.0 mg/dl
- 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
ASP1585 group
Arm Description
Outcomes
Primary Outcome Measures
Time-course changes in serum phosphorus levels
Secondary Outcome Measures
Achievement rate of the target range of serum phosphorus level
Time to achieve the target range of serum phosphorus level
Time-course changes in serum calcium levels
Time-course changes in serum intact PTH (parathyroid hormone) levels
Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01742611
Brief Title
Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
Official Title
ASP1585 Phase 3 Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (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 patients with hyperphosphatemia not on dialysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Renal Insufficiency, Hyperphosphatemia
Keywords
CKD, Not on dialysis, ASP1585, Bixalomer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASP1585 group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ASP1585
Other Intervention Name(s)
LY101, AMG223, bixalomer
Intervention Description
oral
Primary Outcome Measure Information:
Title
Time-course changes in serum phosphorus levels
Time Frame
During 48 week treatment
Secondary Outcome Measure Information:
Title
Achievement rate of the target range of serum phosphorus level
Time Frame
During 48 week treatment
Title
Time to achieve the target range of serum phosphorus level
Time Frame
During 48 week treatment
Title
Time-course changes in serum calcium levels
Time Frame
During 48 week treatment
Title
Time-course changes in serum intact PTH (parathyroid hormone) levels
Time Frame
During 48 week treatment
Title
Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs
Time Frame
During 48 week treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who completed study 1585-CL-0101 or new patients who meet following criteria
Chronic kidney disease patients (eGFR < 60 mL/min/1.73 m2)
Serum phosphorus measurement ≧4.6 mg/dl, <9.0 mg/dl
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
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Chubu
Country
Japan
City
Hokkaido
Country
Japan
City
Kansai
Country
Japan
City
Kanto
Country
Japan
City
Kyushu
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
We'll reach out to this number within 24 hrs