A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
Phase 3
Completed
- Conditions
- Renal InsufficiencyChronic Kidney DiseaseHyperphosphatemia
- Interventions
- Drug: placebo
- Registration Number
- NCT01742585
- Lead Sponsor
- Astellas Pharma Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
Inclusion 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 within 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo group placebo - ASP1585 group ASP1585 -
- Primary Outcome Measures
Name Time Method Change from baseline in serum phosphorus level at the end of treatment Baseline and Week 12 or treatment discontinuation
- Secondary Outcome Measures
Name Time Method Time to achieve the target range of serum phosphorus level During 12 week treatment Achievement rate of 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