Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
ASP1585 Phase 3 Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
1 other identifier
interventional
105
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2013
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2012
CompletedFirst Posted
Study publicly available on registry
December 5, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJune 9, 2015
June 1, 2015
2.1 years
December 4, 2012
June 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time-course changes in serum phosphorus levels
During 48 week treatment
Secondary Outcomes (5)
Achievement rate of the target range of serum phosphorus level
During 48 week treatment
Time to achieve the target range of serum phosphorus level
During 48 week treatment
Time-course changes in serum calcium levels
During 48 week treatment
Time-course changes in serum intact PTH (parathyroid hormone) levels
During 48 week treatment
Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs
During 48 week treatment
Study Arms (1)
ASP1585 group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Chūbu, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kansai, Japan
Unknown Facility
Kanto, Japan
Unknown Facility
Kyushu, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2012
First Posted
December 5, 2012
Study Start
March 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
June 9, 2015
Record last verified: 2015-06