A Phase 2, Open-label Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

7791-003

To evaluate the effect and safety of a switch from phosphate binders to KHK7791 to treat Hyperphosphatemia in patients on HD.

2018-12-27

2019-11-26

2019-11-26

Completed

Early phase I

67

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. 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. * Severe heart disease (including congestive heart failure, defined as New York Heart Association \[NYHA\] cardiac functional classification of Class III or IV, and vascular lesions requiring hospitalization such as myocardial infarction), hepatic impairment (including AST/ALT ≥ 100 U/L before the start of observation period), or concurrent cirrhosis. * Developed cerebrovascular disease (such as cerebral infarction and cerebral hemorrhage) or cardiovascular disease (such as acute myocardial infarction and unstable angina) requiring hospitalization within 6 months before screening examination. * Uncontrollable hypertension or diabetes * 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 (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 67, 'type': 'ACTUAL'}}

2024-03-07