A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
ASP1585 Phase 3 Randomized Double Blind Placebo-controlled Study in Chronic Kidney Disease (CKD) Patients With Hyperphosphatemia Not on Dialysis
1 other identifier
interventional
163
1 country
5
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.
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 Oct 2012
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
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 4, 2012
CompletedFirst Posted
Study publicly available on registry
December 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJuly 16, 2014
July 1, 2014
1.6 years
December 4, 2012
July 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in serum phosphorus level at the end of treatment
Baseline and Week 12 or treatment discontinuation
Secondary Outcomes (5)
Achievement rate of the target range of serum phosphorus level
During 12 week treatment
Time to achieve the target range of serum phosphorus level
During 12 week treatment
Time-course changes in serum phosphorus levels
During 12 week treatment
Time-course changes in serum calcium levels
During 12 week treatment
Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs
During 12 week treatment
Study Arms (2)
ASP1585 group
EXPERIMENTALplacebo group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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 within 6 months
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
Related Publications (1)
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVED
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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2012
First Posted
December 5, 2012
Study Start
October 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
July 16, 2014
Record last verified: 2014-07