Chronic Kidney Disease, Renal Dialysis, Renal Insufficiency
Conditions
Keywords
Hyperphosphatemia, Peritoneal dialysis, CKD, ASP1585
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.
Interventions
DRUGASP1585
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
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 |
|---|---|
| Serum phosphorus level at treatment discontinuation | During the 12-week treatment period |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed