Back to resultsA Phase 3 Study of ASP1585 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
placebo
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:
- 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 within 6 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ASP1585 group
placebo group
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in serum phosphorus level at the end of treatment
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 phosphorus levels
Time-course changes in serum calcium 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
NCT01742585
Brief Title
A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
Official Title
ASP1585 Phase 3 Randomized Double Blind Placebo-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia Not on Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (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 randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of ASP1585 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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASP1585 group
Arm Type
Experimental
Arm Title
placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ASP1585
Other Intervention Name(s)
LY101, AMG223, bixalomer
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Change from baseline in serum phosphorus level at the end of treatment
Time Frame
Baseline and Week 12 or treatment discontinuation
Secondary Outcome Measure Information:
Title
Achievement rate of the target range of serum phosphorus level
Time Frame
During 12 week treatment
Title
Time to achieve the target range of serum phosphorus level
Time Frame
During 12 week treatment
Title
Time-course changes in serum phosphorus levels
Time Frame
During 12 week treatment
Title
Time-course changes in serum calcium levels
Time Frame
During 12 week treatment
Title
Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs
Time Frame
During 12 week treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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 within 6 months
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
A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
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