Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Exclusion Criteria

• •1. Peritoneal dialysis was performed within 12 weeks before screening examination.
• •2. iPTH \> 600 pg/mL (should be based on the most recent value from patient's medical records before pre-enrollment)
• •3. History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome
• •4. History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination.
• •5. Subjects who used anti RANKL preparations within 6 weeks before screening examination.
• •6. Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.
• •7. Severe heart disease, hepatic impairment, or concurrent cirrhosis.
• •8. Developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination.
• •9. Uncontrollable hypertension or diabetes
• •10. 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.
• •11. 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.
• •12. Any diagnosis of or treatment of malignancy within 5 years before screening examination.