Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Inclusion criteria

• Has voluntarily provided written informed consent to participate in the study.
• Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent.
• Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
• Dialysis conditions excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
• The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.
• Serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 7.0 mg/dL at screening examination.
• If on any vitamin D, calcimimetics regimen, bisphosphonate,calcitonin preparations, selective estrogen receptor modulators or teriparatide preparations then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
• Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination.

Exclusion criteria

• Peritoneal dialysis was performed within 12 weeks before screening examination.
• 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.
• Subjects who used anti RANKL preparations within 6 weeks before screening examination.
• Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.
• Severe heart disease, hepatic impairment, or concurrent cirrhosis.
• Developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination.
• Uncontrollable hypertension or diabetes
• Subjects experienced more than 3 times diarrhea or loose stool in a day at least six BSFS score more than two days in a week.
• Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis or plans to change the dialysis center (relocate to another hospital/clinic) during the study period.
• Any diagnosis of or treatment of malignancy within 5 years before screening examination.