A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis
Phase 3
Completed
- Conditions
- Renal DialysisRenal InsufficiencyChronic Kidney Disease
- Interventions
- Drug: ASP1585
- Registration Number
- NCT01017276
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 in chronic kidney disease and hyperphosphatemia patients on peritoneal dialysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- Chronic kidney disease patients on peritoneal dialysis
- Hyperphosphatemia
- Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not changed within 28 days.
- Written informed consent
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ASP group ASP1585 -
- Primary Outcome Measures
Name Time Method Serum phosphorus level at treatment discontinuation During the 12-week treatment period
- Secondary Outcome Measures
Name Time Method Percent of the patients meeting the target range of serum phosphorus levels During treatment Time-course changes in serum calcium levels During Treatment Changes in serum Ca x P During Treatment Changes in intact PTH levels During Treatment