Chronic Kidney Disease, Hyperphosphatemia, Renal Insufficiency
Conditions
Keywords
CKD, Not on dialysis, ASP1585, Bixalomer
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.
Interventions
DRUGASP1585
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-course changes in serum phosphorus levels | During 48 week treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed