Hyperphosphatemia patients on hemodialysis
Conditions
Sponsors
Kyowa Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with stable chronic renal failure who have undergone hemodialysis three times per week for at least 12 weeks until screening examination. 2) Dialysis conditions (dialysate, dialyzer, frequency of dialysis per week, dialysis duration, blood flow rate, and dialysate and substitution fluid flow rates), excluding dry weight, should have been unchanged during the last 2 weeks before screening examination. 3) Taking phosphate binders three times per day. The prescribed drug and dosage regimen should have been unchanged during the last 2 weeks before screening examination. 4) Serum phosphorus levels should be in the range of >=6.1 and <10.0 mg/dL at screening examination.
Exclusion criteria
Exclusion criteria: 1) iPTH >600 pg/mL 2) Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome 3) 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 Changes in serum phosphorus levels from baseline values at Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Adverse events | — |
Countries
Japan
Outcome results
None listed