Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
Phase 3
Completed
- Conditions
- HyperphosphatemiaChronic Kidney DiseaseRenal Insufficiency
- Interventions
- Registration Number
- NCT01742611
- 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 for long-term dosing in chronic kidney disease patients with hyperphosphatemia not on dialysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
Inclusion Criteria
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ASP1585 group ASP1585 -
- Primary Outcome Measures
Name Time Method Time-course changes in serum phosphorus levels During 48 week treatment
- Secondary Outcome Measures
Name Time Method 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