A Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HD

Kyowa Kirin

Status and phase

Completed

Phase 2

Conditions

Hyperphosphatemia

Treatments

Drug: KHK7791

Study type

Interventional

Funder types

Industry

Identifiers

7791-003

Details and patient eligibility

About

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

Enrollment

67 patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

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).