Chronic Kidney Disease, Hyperphosphatemia, Renal Insufficiency
Conditions
Keywords
CKD, Not on dialysis, ASP1585, Bixalomer
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.
Interventions
DRUGASP1585
oral
DRUGplacebo
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in serum phosphorus level at the end of treatment | Baseline and Week 12 or treatment discontinuation |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
Japan
Outcome results
None listed