A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis
Study Details
Study Description
Brief Summary
This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on hemodialysis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: ASP group
|
Drug: ASP1585
oral
Other Names:
|
Active Comparator: Sevelamer group
|
Drug: Sevelamer hydrochloride
oral
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Serum phosphorus level at the end of treatment [After 12-week or at the treatment discontinuation]
Secondary Outcome Measures
- Change in serum phosphorus level [After 12-week or at the end of treatment]
- Time-course changes in serum phosphorus levels [During Treatment]
- Changes in serum Ca x P [During treatment]
- Changes in intact PTH levels [During Treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Chronic kidney disease patients on hemodialysis
-
Hyperphosphatemia
-
Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not been 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
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Patients with uncontrolled hypertension
-
Patients treated with parathyroid intervention
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Chubu | Japan | |||
2 | Kantou | Japan | |||
3 | Kyusyu | Japan |
Sponsors and Collaborators
- Astellas Pharma Inc
Investigators
- Study Chair: Use Central Contact, Astellas Pharma Inc
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1585-CL-0003