Hyperphosphatemia
Conditions
Sponsors
Kyowa Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination. - Met certain conditions for dialysis excluding Dry Weight (Dialysate, Dialyzer, Frequency of Dialysis per Week, Dialysis Time, Blood Flow Rate, and Dialysate and Substitution Fluid Flow Rate) 2 weeks before screening examination. - Taking at least 2 tablets of phosphate binder 3 times per day. The prescribed dosage regimen should have been unchanged for the period from 2 weeks before screening examination through pre-enrollment. - Serum phosphorus levels should be between 3.5 and 7.0 mg/dL (inclusive) at screening examination. - If on any vitamin D or calcimimetics regimen, the dosage regimen should have been unchanged for the last 2 weeks before screening examination. etc
Exclusion criteria
Exclusion criteria: - iPTH > 600 pg/mL (should be based on the most recent value from patient`s medical records before pre-enrollment) - History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome - History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination. etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Decrease in taking volume of phosphate binder | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Adverse event | — |
Countries
Japan
Outcome results
None listed